ALFA GATE Dental Implants System
Device Facts
| Record ID | K182143 |
|---|---|
| Device Name | ALFA GATE Dental Implants System |
| Applicant | Alfa Gate Mazen, Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Oct 3, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
ALFA GATE® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. ALFA GATE® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. ALFA GATE® 3.00mm S-LINE & SLIM implants are intended for placement at the mandibular central and lateral incisors and maxillary lateral incisors. Indicated also for denture stabilization using multiple implants. Two Stage Implants: M+, S-LINE, SCI, SCIP, MAX. One Stage Implants: SLIM Implants. ALFA GATE Dental Implants longer than 13mm are to be used with straight abutments only.
Device Story
System consists of endosseous dental implants (M+, S-LINE, SCI, SCIP, MAX, SLIM) and various abutments (straight, angled, multi-unit, ball attachment, etc.). Implants are surgically placed in the jawbone by dental professionals to support prosthetic restorations. Implants feature tapered, double-thread designs and are available with either Bioactive (CaP) or sand-blasted/acid-etched surface treatments. Abutments connect to implants via internal hex or conical connections to support crowns, bridges, or overdentures. System provides immediate loading capability when primary stability is achieved. Benefits include restoration of oral function and aesthetics for edentulous or partially edentulous patients.
Clinical Evidence
No clinical data included. Bench testing only: Sterilization validation (ISO 11137, ISO 17665), shelf-life testing (ASTM F-1980), fatigue testing (ISO 14801), biocompatibility (ISO 10993-5, ISO 10993-10), and surface cleanliness analysis.
Technological Characteristics
Materials: Titanium alloy Ti-6Al-4V ELI (ISO 5832-3). Design: Endosseous root-form implants with internal hex or conical connections. Surface: Bioactive (CaP) or sand-blasted/acid-etched. Sterilization: Gamma irradiation (implants); autoclave (abutments). Connectivity: Mechanical connection between implant and abutment.
Indications for Use
Indicated for edentulous or partially edentulous patients requiring surgical placement of dental implants in the maxillary or mandibular arch to support crowns, bridges, or overdentures. Specific implants (3.0mm S-LINE & SLIM) indicated for mandibular central/lateral incisors and maxillary lateral incisors. Indicated for denture stabilization using multiple implants.
Regulatory Classification
Identification
An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Special Controls
*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
Predicate Devices
- SGS International Itd - SGS Dental Implants System (K182219)
Reference Devices
- SGS International Itd - SGS Dental Implants System (K133362)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 3, 2019
Alfa Gate Mazen Ltd % Daniela Levy Regulatory Consultant Sterling Medical Registration 22815 Ventura Blvd Woodland Hills, California 91364
Re: K182143
Trade/Device Name: ALFA GATE® Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 9, 2019 Received: July 9, 2019
Dear Daniela Levy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a circular icon with a gradient of colors from yellow to green on the left, followed by the text "AlfaGate" in a dark blue, sans-serif font. Below the name, the words "DENTAL IMPLANTS EXPERTS" are written in a smaller, lighter font.
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# SECTION 4 -
# Indication for Use Statement
510(k) Number (if known): K182143 Device Name: ALFA GATE® Dental Implants System Indications for Use (Describe)
## Indications for Use:
ALFA GATE® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. ALFA GATE® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. ALFA GATE® 3.00mm S-LINE & SLIM implants are intended for placement at the mandibular central and lateral incisors and maxillary lateral incisors. Indicated also for denture stabilization using multiple implants. Two Stage Implants: M+, S-LINE, SCI, SCIP, MAX. One Stage Implants: SLIM Implants.
ALFA GATE Dental Implants longer than 13mm are to be used with straight abutments only.
Type of Use (Select one or both, as applicable)
凶 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use(21 CFR 801 Subpart
#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a colorful hexagon-shaped icon on the left and the company name "AlfaGate" in a bold, dark blue font on the right. Below the company name, the words "DENTAL IMPLANTS EXPERTS" are written in a smaller, lighter font.
# SECTION 5 -
# 510(k) Number K182143
| 1 | Type of Submission Premarket Notification (21 CFR 807.90(e)) 510(k) Traditional | | |
|---|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| 2 | Submission Owner | ALFA GATE MAZEN LTD. | |
| | | Dr. Mohamad Zahalka - CEO | |
| | | Hitin st.2, P.O.BOX 301 | |
| | | Kfar Qara 3007500, Israel | |
| | | Tel | : +972-4-6356686 |
| | | Fax | : +972-4-6354466 |
| 3 | Official Correspondent<br>Contact Person | Sterling Medical Registration<br>Daniela Levy - Regulatory Consultant<br>22815 Ventura blvd.<br>Woodland Hills, CA 91364<br>Phone: 1-213-787-3027<br>Email: sterlingmedical2017@gmail.com;<br>daniela@sterlingmedicalregistration.com | |
| 4 | Date Prepared | October 3rd, 2019 | |
| 5 | Device Trade Name | ALFA GATE® Dental Implants System | |
| 6 | Regulation Description | Endosseous Dental Implants | |
| 7 | Classification | Product Code | : DZE |
| | | Device Name | : Implant, endosseous, root-form |
| | | Regulation No | : 872.3640 |
| | | Class | : II |
| | | Panel | : Dental |
| | | Secondary Product Code | : NHA |
| 8 | Reason for the Premarket Notification Submission | : New Device | |
- 9 Identification of Legally Marketed Predicate Devices : Primary Predicate:
SGS International Itd - SGS Dental Implants System K182219;
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Image /page/4/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a circular design on the left, made up of three curved shapes in different colors: orange, yellow, green, and blue. To the right of the circular design is the text "AlfaGate" in a dark blue, sans-serif font. Below "AlfaGate" is the text "DENTAL IMPLANTS EXPERTS" in a smaller, sans-serif font.
Reference Devices:
SGS International Itd - SGS Dental Implants System K133362;
- 10 Device Description:
ALFA GATE® Dental Implant System is consist of endosseous form Dental Implants, Internal hex Implants, Internal Conical Connection Implants, One piece Implants, tapered design; cover screws, healing caps and abutment systems; Dental Implants are provided in two options of surface treatment (1) Bioactive Surface-CaP which is a calcium phosphate coating; or (2) Sand blast large particles with acid etched;
Dental Implants:
M+ IMPLANTS - Internal Hex, Conical Connection Implant
Measurements: Diameter mm 3.5, 4.3, 5.0, 6.0; with Length mm 8, 10, 11.5, 13, 16(not for 60 mm);
S-LINE Implants - Internal Hex implant, Narrow Implants
BIOACTIVE S-LINE Implant - Measurements: Diameter mm 3.0 with Length mm 10, 11.5, 13;
POROUS S-LINE Implant - Measurements: Diameter mm 3.0 with Length mm 10, 11.5, 13:
SCI Implants - Internal Hex implant, Spiral conical design
BIOACTIVE SCI Implant - Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2, 6.0 with Length mm 8, 10, 11.5, 13, 16 (not for 5.20,60 mm);
POROUS SCIP Implant - Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2, 6.0 with Length mm 8, 10, 11.5, 13, 16 (not for 5.2Ø,6Ø mm):
MAX Implant - Internal hex implant, cylindrical and conical body design
Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2 with Length mm 8, 10, 11.5, 13, 16;
SLIM Implant - One Piece implants
Measurements: Diameter mm 3.0, 3.3, 3.75 with Length mm 10, 11.5, 13, 15;
Dental Abutments:
Straight abutments (Regular, Thin, Wide, Narrow), Angled Abutments 15° (Regular, Short), Multi Unit, Shoulder abutments, Esthetic Abutments, Concave Esthetic Abutments, Esthetic Abutments 15°, Concave Angulated Abutments 15°, Esthetic Abutments , Alfa lock abutment (locator), Ball attachment Abutment, Ball attachment
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Image /page/5/Picture/0 description: The image is a logo for AlfaGate Dental Implants Experts. The logo features a colorful, circular icon on the left, made up of six segments in different colors: blue, green, yellow, and orange. To the right of the icon is the company name, "AlfaGate," in a bold, dark blue font. Below the name, in smaller letters, is the tagline "DENTAL IMPLANTS EXPERTS."
concave, Healing Caps (Narrow, Regular, Wide, Slim), Concave healing caps, Anatomic Abutment. Angled abutments are only to be used with S-Line, SCI, and MAX implants. M+ and SLIM implants are not to be used with angled abutments. Dental Abutments Conical Connection:
Anatomic straight Abutment (RP, NP), Standard straight abutment (RP, NP), Ball attachment (RP, NP), Healing Caps (RP, NP).
- 11 Indication for Use
ALFA GATE® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. ALFA GATE® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. ALFA GATE® 3.0Ømm S-LINE & SLIM implants are intended for placement at the mandibular central and lateral incisors and maxillary lateral incisors. Indicated also for denture stabilization using multiple implants. Two Stage Implants: M+, S-LINE, SCI, SCIP, MAX. One Stage Implants: SLIM Implants.
ALFA GATE Dental Implants longer than 13mm are to be used with straight abutments only.
- 12 Performance Standards or Guidance Documents
- . ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
- ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought . titanium 6-aluminium 4-vanadium alloy.
- ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatique test for . endosseous dental implants.
- ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: . Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11737-2: 2009 Sterilization of medical devices -- Microbiological methods --. Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ASTM F-1980 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems . for Medical Devices
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Image /page/6/Picture/0 description: The image contains the logo for AlfaGate Dental Implants Experts. The logo consists of a circular icon on the left and the company name on the right. The circular icon is made up of six segments, each with a different color: blue, teal, green, yellow, orange, and light blue. The company name is written in a dark blue sans-serif font, with the words "DENTAL IMPLANTS EXPERTS" written in a smaller font below.
- ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 17665-2:2009 Sterilization of health care products -- Moist heat -- Part 2: . Guidance on the application of ISO 17665-1
- . ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in . vitro cytotoxicity
- . FDA guidance document: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.
- Chemical and SEM analysis performed on implants per Class II Special Controls . Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.
- Endotoxin batch testing protocol per FDA Guidance Document Submission and . Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and . Labeling Guidance for Industry and Food and Drug Administration Staff.
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices . - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff
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Image /page/7/Picture/0 description: The image is a logo for AlfaGate. The logo consists of a hexagon made of six different colored sections on the left, and the text "AlfaGate" in a dark blue font on the right. Below the text "AlfaGate" is the text "DENTAL IMPLANTS EXPERTS" in a smaller, lighter blue font.
#### 13 Substantial Equivalence
#### SE Table - Indication for Use:
| | Candidate | Primary Predicate | Reference Device |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ALFA GATE | SGS International | SGS International |
| K Number | K182143 | K182219 | K133362 |
| Indication for use | ALFA GATE® Dental Implants<br>System is intended for surgical<br>placement in the maxillary<br>and/or mandibular arch to<br>support crowns, bridges, or<br>overdentures in edentulous or<br>partially edentulous patients.<br>ALFA GATE® Dental Implants<br>System may be immediate<br>loading when good primary<br>stability is achieved and with<br>appropriate occlusal loading.<br>ALFA GATE® 3.00mm S-LINE &<br>SLIM implants are intended for<br>placement at the mandibular<br>central and lateral incisors and<br>maxillary lateral incisors.<br>Indicated also for denture<br>stabilization using multiple<br>implants. Two Stage Implants:<br>M+, S-LINE, SCI, SCIP, MAX. One<br>Stage Implants: SLIM Implants.<br>ALFA GATE Dental Implants<br>longer than 13mm are to be<br>used with straight abutments<br>only. | SGS® Dental Implants System is<br>intended for surgical placement<br>in the maxillary and/or<br>mandibular arch to support<br>crowns, bridges, or overdentures<br>in edentulous or partially<br>edentulous patients. SGS® Dental<br>Implants System may be<br>immediate loading when good<br>primary stability is achieved and<br>with appropriate occlusal loading.<br>Narrow diameter implants (3.2)<br>are intended for maxillary lateral<br>incisors and mandibular lateral<br>and central incisors.<br>Two Stage Implants: P7N, P1D,<br>P5D, P7D. PEEK Temporary<br>Abutments are not to exceed 30<br>days. | SGS® Dental Implants System is<br>intended for surgical placement<br>in the maxillary and/or<br>mandibular arch to support<br>crowns, bridges, or overdentures<br>in edentulous or partially<br>edentulous patients. SGS® Dental<br>Implants System may be<br>immediate loading when good<br>primary stability is achieved and<br>with appropriate occlusal loading.<br>Two Stage Implants: P1, P7, P7N.<br>One Stage: P7S, P9S.<br>One Stage & One-Piece 3.0 mm<br>diameter implants: P7S, P9S are<br>intended for placement at the<br>mandibular central and lateral<br>incisors and maxillary and lateral<br>incisors. Indicated also for<br>denture stabilization using<br>multiple implants.<br>One stage & One-Piece 2.4 mm<br>diameter implants for temporary<br>use or long term use:<br>P9S permit immediate splint<br>stability and long term fixation of<br>new or existing crown, bridge and<br>prosthesis, and protection of<br>graft sites.<br>PEEK Temporary Abutments are<br>not to exceed 30 days. |
#### SE - Indication for Use Discussion -
The candidate ALFA GATE SLIM share the same indication for use as its primary predicate SGS K182219 and reference device SGS K133362. Minor differences are that SGS K133362 introduces smaller onepiece implants and narrow implants with 2.4ø, where ALFA GATE introduces the SLIM onepiece implants and S-LINE narrow implants with 3.0ø. However still sharing the same indication and therefore, ALFA GATE can be considered to be substantially equivalent to its reference device.
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Image /page/8/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a hexagonal shape made up of six curved segments, each in a different color: blue, light blue, green, light green, yellow, and orange. To the right of the shape is the text "AlfaGate" in a dark blue, sans-serif font, with the words "DENTAL IMPLANTS EXPERTS" in a smaller font below.
### SE - Dental Implan
| Characteristic | Candidate<br>M+ Implants<br>(Cat# SCA) | Primary Predicate<br>P7D - Dental Implant with Double<br>Connection |
|----------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K182143 | K182219 |
| Manufacturer | Alfa Gate Mazen Ltd | SGS International Itd |
| Product Name | M+ Implants | P7D - Dental Implant with Double<br>Connection |
| Thread Design | Tapered, Double Thread | Tapered, Double Thread |
| Measurements<br>mm | 3.5 Ø: 8 ,10, 11.5, 13, 16<br>4.3 Ø: 8 ,10, 11.5, 13, 16<br>5.0 Ø: 8 ,10, 11.5, 13, 16<br>6.0 Ø: 8 ,10, 11.5, 13 | 3.5 Ø: 8, 10, 11.5, 13, 16<br>3.75 Ø: 8, 10, 11.5, 13, 16<br>4.2 Ø: 8, 10, 11.5, 13, 16<br>4.5 Ø: 8, 10, 11.5, 13, 16<br>5.0 Ø: 8, 10, 11.5, 13, 16<br>6.0 Ø: 8, 10, 11.5, 13, 16 |
| Connection<br>Type | Internal hex conical connection, cone<br>angulation 23.5° | Internal hex conical connection , cone<br>angulation 18° |
| Material | Ti 6Al-4V ELI | Ti 6Al-4V ELI |
| Surface<br>Treatment | Sand Blast and acid-etched | Calcium Phosphate Coating |
| Self tapping | ✓ | ✓ |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |
SE Discussion
## Technical Parameters comparison:
The candidate ALFA GATE M+ Implants share the same implant design, raw materials and implants' measurements as its primary predicate SGS K182219. The differences are related to the cone angulation, diameter and surface treatment. ALFA GATE cone angulation is 23.5°, Primary Predicate SGS cone angulation is 18°. This is considered to be minor difference as verified by Fatigue Test results. ALFA GATE introduces 4.3ø where the primary predicate SGS K182219 introduces 4.2ø however this is considered to be minor differences as this is covered by the range of the primary predicate SGS K182219. The implant surface is Sand Blasted and acid-etched, which is demonstrated as substantially equivalent per recommendations of the FDA Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Therefore ALFA GATE M+ Implants can be considered substantially equivalent to its primary predicate SGS K182219.
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Image /page/9/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a colorful, circular graphic to the left of the company name, which is written in a dark blue, stylized font. Below the company name, the words "DENTAL IMPLANTS EXPERTS" are written in a smaller, sans-serif font.
| Characteristic | Candidate<br>BIOACTIVE S-LINE<br>Implant (Cat# S-LINE) | Candidate<br>POROUS S-LINE<br>Implant (Cat# S-LINE) | Reference Device<br>SGS P7N Narrow Conical Implant |
|----------------------|--------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------|
| 510(k)number | K182143 | K182143 | K133362 |
| Manufacturer | Alfa Gate Mazen Ltd | Alfa Gate Mazen Ltd | SGS International Ltd |
| Product Name | BIOACTIVE S-LINE<br>Implant | POROUS S-LINE<br>Implant | P7N Narrow Conical Implant |
| Thread Design | Tapered, Double<br>Thread | Tapered, Double<br>Thread | Tapered, Double Thread |
| Measurements<br>mm | 3.0 Ø: 10, 11.5, 13 | 3.0 Ø: 10, 11.5, 13 | 3.0 Ø: 10, 11.5, 13, 16<br>3.2 Ø: 10, 11.5, 13, 16 |
| Connection | Internal Hex | Internal Hex | Internal Hex |
| Material | Ti 6Al-4V ELI | Ti 6Al-4V ELI | Ti 6Al-4V ELI |
| Surface<br>Treatment | Calcium Phosphate<br>Coating | Sandblasted and<br>acid etched | Calcium Phosphate Coating |
| Self tapping | ✓ | ✓ | ✓ |
| Sterilization | Gamma Ray | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging | Double packaging |
#### Technical Parameters comparison:
The candidate ALFA GATE BIOACTIVE S-LINE & POROUS S-LINE Implants share the same implant design, raw materials and implants' measurements as its reference device SGS K133362. Minor difference is related to implant surface, ALFA GATE BIOACTIVE S-LINE Implant is provided with surface treatment of Calcium Phosphate & HA as in similar to its reference device. Where the ALFA GATE POROUS S-LINE is provided with surface treatment of Sand Blast and acid etched, which is demonstrated as substantially equivalent per recommendations of the FDA Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Therefore, ALFA GATE BIOACTIVE S-LINE & POROUS S-LINE Implants can be considered substantially equivalent to its reference device SGS K133362.
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Image /page/10/Picture/0 description: The image shows the logo for AlfaGate, a dental implant company. The logo consists of a colorful, hexagonal shape on the left, followed by the company name in a dark blue, sans-serif font. Below the company name, the words "DENTAL IMPLANTS EXPERTS" are written in a smaller, sans-serif font.
| Characteristic | Candidate<br>BIOACTIVE SCI Implant<br>(Cat# SCI) | Candidate<br>POROUS SCIP Implant<br>(Cat# SCIP) | Reference Device<br>SGS P1 Screw Type Groovy<br>Implant |
|-------------------|--------------------------------------------------|-------------------------------------------------|---------------------------------------------------------|
| 510(k)number | K182143 | K182143 | K133362 |
| Manufacturer | Alfa Gate Mazen Ltd | Alfa Gate Mazen Ltd | SGS International Ltd |
| Product Name | BIOACTIVE SCI Implant | POROUS SCIP Implant | P1 Screw Type Groovy Implant |
| Thread Design | Tapered, Double Thread | Tapered, Double | Tapered, Double Thread |
| Measurements mm | 3.3 Ø: 8, 10, 11.5, 13, 16 | 3.3 Ø: 8, 10, 11.5, 13, 16 | 3.2 Ø: 8, 10, 11.5, 13, 16 |
| | 3.75 Ø: 8, 10, 11.5, 13, 16 | 3.75 Ø: 8, 10, 11.5, 13, 16 | 3.75 Ø: 8, 10, 11.5, 13, 16 |
| | 4.2 Ø: 8, 10, 11.5, 13, 16 | 4.2 Ø: 8, 10, 11.5, 13, 16 | 4.2 Ø: 8, 10, 11.5, 13, 16 |
| | 4.7 Ø: 8, 10, 11.5, 13, 16 | 4.7 Ø: 8, 10, 11.5, 13, 16 | 4.5 Ø: 8, 10, 11.5, 13, 16 |
| | 5.2 Ø: 8, 10, 11.5, 13 | 5.2 Ø: 8, 10, 11.5, 13 | 5.0 Ø: 8.,10, 11.5, 13, 16 |
| | 6.0 Ø: 8, 10, 11.5, 13 | 6.0 Ø: 8, 10, 11.5, 13 | 6.0 Ø:8, 10, 11.5, 13, 16 |
| Connection | Internal Hex | Internal Hex | Internal Hex |
| Material | Ti 6Al-4V ELI | Ti 6Al-4V ELI | Ti 6Al-4V ELI |
| Surface | Calcium Phosphate<br>Coating | Sandblasted and acid<br>etched | Calcium Phosphate Coating |
| Surface Treatment | Coating | etched | |
| Self tapping | ✓ | ✓ | ✓ |
| Sterilization | Gamma Ray | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging | Double packaging |
#### Technical Parameters comparison:
The candidate ALFA GATE BIOACTIVE SCI & POROUS SCIP Implants share the same implant design, raw materials and implants' measurements as its reference device SGS K133362. Minor difference is related to implant surface, ALFA GATE BIOACTIVE SCI Implant is provided with surface treatment of Calcium Phosphate & HA as in similar to its reference device. Where the ALFA GATE POROUS SCIP is provided with surface treatment of Sand Blast and acid etched, which is demonstrated as substantially equivalent per recommendations of the FDA Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Therefore, ALFA GATE BIOACTIVE SCI & POROUS SCIP Implants can be considered substantially equivalent to its reference device SGS K133362.
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Image /page/11/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a circular design with six sections, each in a different color: blue, green, yellow, and orange. To the right of the circular design is the text "AlfaGate" in a dark blue, sans-serif font. Below "AlfaGate" is the text "DENTAL IMPLANTS EXPERTS" in a smaller, sans-serif font.
| Characteristic | Candidate<br>MAX Dental Implants<br>(Cat# MAX) | Reference Device<br>SGS P1 Screw Type Groovy Implant |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K182143 | K133362 |
| Manufacturer | Alfa Gate Mazen Ltd | SGS International Ltd |
| Product Name | MAX Implants | P1 Screw Type Groovy Implant |
| Thread Design | Tapered, Double Thread | Tapered, Double Thread |
| Measurements<br>mm | 3.3 Ø: 8, 10, 11.5, 13, 16<br>3.75 Ø: 8, 10, 11.5, 13, 16<br>4.2 Ø: 8, 10, 11.5, 13, 16<br>4.7 Ø: 8, 10, 11.5, 13, 16<br>5.2 Ø: 8, 10, 11.5, 13 | 3.2 Ø: 8, 10, 11.5, 13, 16<br>3.75 Ø: 8, 10, 11.5, 13, 16<br>4.2 Ø: 8, 10, 11.5, 13, 16<br>4.5 Ø: 8, 10, 11.5, 13, 16<br>5.0 Ø: 8, 10, 11.5, 13, 16<br>6.0 Ø: 8, 10, 11.5, 13, 16 |
| Connection | Internal hex | Internal Hex |
| Material | Ti 6Al-4V ELI | Ti 6Al-4V ELI |
| Surface | Sand Blast and acid-etched | Calcium Phosphate Coating |
| Self tapping | ✓ | ✓ |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |
#### Technical Parameters comparison:
The candidate ALFA GATE MAX Implants share the same implant design, raw materials and implants' measurements as its reference device SGS K133362. Minor difference is related to implant surface, the ALFA GATE MAX implant is provided with surface treatment of Sand Blast and acid etched, which is demonstrated as substantially equivalent per recommendations of the FDA Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Therefore, ALFA GATE MAX Implants can be considered substantially equivalent to its reference device SGS K133362.
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a circular design with six sections, each in a different color: blue, green, yellow, orange, yellow, and green. To the right of the circular design is the text "AlfaGate" in a dark blue, sans-serif font. Below "AlfaGate" is the text "DENTAL IMPLANTS EXPERTS" in a smaller, sans-serif font.
| Characteristic | Candidate<br>SLIM Implants (Cat# SCA) | Reference Device<br>SGS P7S Integral Groovy Implant |
|--------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K182143 | K133362 |
| Manufacturer | Alfa Gate Mazen Ltd | SGS International Ltd |
| Product Name | SLIM Implants | P7S Integral Groovy Implant |
| Thread Design | Tapered, Double Thread | Tapered, Double Thread |
| Measurements<br>mm | 3.0 Ø: 10, 11.5, 13, 15<br>3.3 Ø: 10, 11.5, 13, 15<br>3.75 Ø: 10, 11.5, 13, 15 | 3.0 Ø: 10, 11.5, 13, 16<br>3.2 Ø: 10, 11.5, 13, 16<br>3.75 Ø: 10, 11.5, 13, 16<br>4.2 Ø: 10, 11.5, 13, 16<br>5.0 Ø: 10, 11.5, 13, 16<br>6.0 Ø: 10, 11.5, 13, 16 |
| Connection | One piece implant | One piece implant |
| Material | Ti 6Al-4V ELI | Ti 6Al-4V ELI |
| Surface | Calcium Phosphate Coating | Calcium Phosphate Coating |
| Self tapping | ✓ | ✓ |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |
#### Technical Parameters comparison:
The candidate ALFA GATE SLIM Implants share the same implant design, raw materials, implants' measurements and surface treatment as its reference device SGS K133362. Therefore, ALFA GATE SLIM Implants can be considered substantially equivalent to its reference device SGS K133362.
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a hexagon made of curved lines in the colors orange, yellow, green, and blue. To the right of the hexagon is the text "AlfaGate" in a dark blue, sans-serif font, and below that is the text "DENTAL IMPLANTS EXPERTS" in a smaller, lighter font.
## SE - Dental Abutments:
## Internal Hex
| | Candidate | Primary Predicate |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Alfa Gate Mazen Itd | SGS International Itd |
| K Number | K182143 | K182219 |
| Product Name | Straight abutment Cat#AGM-101<br>Straight abutment Cat#AGM-101H | Straight Titanium Abutment<br>S1WN,S1D, S1ND, S1WD, S1W, S1W8D, S1W8 |
| Dimensions mm | Regular (RP), Length: 10.2 | Narrow: Wide - Length:9<br>Normal: Length: 7, 9, 12, 15<br>Narrow: Length: 7, 9<br>Wide: Length:9, 12<br>S1W8D, S1W8 - 8mm wide with 10mm length |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal conical |
| Restoration | Cement Retained | Cement Retained |
| | Candidate | Reference Device |
| | Alfa Gate Mazen Itd | SGS International |
| K Number | K182143 | K133362 |
| Product Name | 15° Abutment Cat#AGM-102 | Angular Titanium Abutment, S2N, S2L, S2A |
| Dimensions mm | Regular (RP), Length: 9.5 - Angle 15 | Narrow: Angle 15°, - length 9 mm<br>Normal: Angle 15°, 25°- Length 9, 11 mm<br>Normal: Height 1,2, 3 Length 9, 11 |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Hex |
| Restoration | Cement Retained | Cement Retained |
| | Candidate | Primary Predicate |
| | Alfa Gate Mazen Itd | SGS International Itd |
| K Number | K182143 | K182219 |
| Product Name | Thin abutment Cat#AGM-104<br>Wide abutment Cat#AGM-110 | Straight Titanium Abutment<br>S1WN,S1D, S1ND, S1WD, S1W, S1W8D, S1W8 |
| Dimensions mm | Thin , Length: 10<br>Wide , Length: 11.5 | Narrow: Wide - Length:9<br>Normal: Length: 7, 9, 12, 15<br>Narrow: Length: 7, 9<br>Wide: Length:9, 12<br>S1W8D, S1W8 - 8mm wide with 10mm length |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal conical |
| Restoration | Cement Retained | Cement Retained |
| | Candidate | Primary Predicate |
| | Alfa Gate Mazen Itd | SGS International Itd |
| K Number | K182143 | K182219 |
| Product Name | High base Abutment Cat#AGM-108 | Straight Titanium Abutment<br>S1WN,S1D, S1ND, S1WD, S1W, S1W8D, S1W8 |
| Dimensions mm | RN , Length: 13.5 mm | Narrow: Wide - Length:9<br>Normal: Length: 7, 9, 12, 15<br>Narrow: Length: 7, 9<br>Wide: Length:9, 12<br>S1W8D, S1W8 - 8mm wide with 10mm length |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal conical |
| Restoration | Cement Retained | Cement Retained |
| | Candidate | Primary Predicate |
| | Alfa Gate Mazen Itd | SGS International Itd |
| K Number | K182143 | K182219 |
| Product Name | Long neck Abutment Cat#AGM-109 | Straight Titanium Abutment<br>S1WN,S1D, S1ND, S1WD, S1W, S1W8D, S1W8 |
| Dimensions mm | RN , Length: 14.5 mm | Narrow: Wide - Length:9<br>Normal: Length: 7, 9, 12, 15<br>Narrow: Length: 7, 9<br>Wide: Length:9, 12<br>S1W8D, S1W8 - 8mm wide with 10mm length |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal conical |
| Restoration | Cement Retained | Cement Retained |
| | Candidate | Primary Predicate |
| | Alfa Gate Mazen Itd | SGS International Itd |
| K Number | K182143 | K182219 |
| Product Name | Angulated abutment 15° S-Line Cat#AGM-115S | Angular Abutments S2D, S2S, S2DS |
| Dimensions mm | NP, Length: 11 - Angle 15 | NP,SLIM Length :11 - Angle 15, ,25 |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal conical |
| Restoration | Cement Retained | Cement Retained |
| | Candidate | Primary Predicate |
| | Alfa Gate Mazen Itd | SGS International Itd |
| K Number | K182143 | K182219 |
| Product Name | S-Line straight abutment Cat# AGM- | S-Lock Abutments S35N, S35D,S35 |
| 100S | | |
| Dimensions mm | NP, Length: 10 mm | Narrow Diameter: 3.0 Height: 1, 2, 3;<br>Regular Diameter: 3.75 Height: 1,2, 3,4,5,6 |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Conical |
| Restoration | Cement Retained | Cement Retained |
| | <b>Candidate</b> | <b>Primary Predicate</b>…
