ZENEX Implant System_Narrow
Device Facts
| Record ID | K230630 |
|---|---|
| Device Name | ZENEX Implant System_Narrow |
| Applicant | Izenimplant Co., Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Jul 31, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.
Device Story
Endosseous dental implant system consisting of fixtures, abutments, and screws; used as artificial root structure for tooth replacement or denture stabilization. Fixtures feature tapered design with macro threads and SLA (sand-blasted, large-grit, acid-etched) surface treatment. Implant-abutment connection utilizes internal hex and Morse taper bevel. Used in clinical dental settings by trained professionals. Fixtures and specific abutments provided sterile; others require end-user sterilization. Output is a stable foundation for prosthetic restoration. Benefits include restoration of chewing function and tooth replacement. Device evaluated for MRI safety via scientific rationale and literature.
Clinical Evidence
No clinical data. Substantial equivalence established via bench testing, including fatigue testing (ISO 14801:2016), bacterial endotoxin testing (USP <85>), sterilization validation, and biocompatibility assessment (ISO 10993-1:2018). MRI safety evaluated via scientific rationale and published literature.
Technological Characteristics
Materials: Ti-6Al-4V ELI (ASTM F-136) and Co-Cr-Mo alloy. Design: Tapered endosseous root-form with internal hex/Morse taper connection. Surface: SLA (sand-blasted, large-grit, acid-etched). Sterilization: Radiation (fixtures/some abutments) or end-user (autoclave).
Indications for Use
Indicated for single tooth replacement of mandibular central/lateral incisors and maxillary lateral incisors, multiple tooth replacement of mandibular incisors (when splinted), and denture stabilization in the anterior mandible and maxilla. Suitable for immediate restoration or immediate function when primary stability and occlusal loading conditions are met.
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
- s-Clean OneQ-SL Narrow Implant System (K161244)
Reference Devices
- OSSTEM Implant System (K161604)
- UF(II) Narrow Implant System (K161987)
- URIS OMNI System (K172100)
- JDentalCare Implant System JDIcon (K182081)
- UV Active Implant System (K182194)
- IS-III active System S-narrow Type (K190849)
- ZENEX Implant System (K211090)
- Magicore Narrow System (K220079)
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 and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Izenimplant Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K230630
Trade/Device Name: ZENEX Implant System Narrow Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 5, 2023 Received: July 5, 2023
Dear April Lee:
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.
# Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K230630
Device Name ZENEX Implant System Narrow
#### Indications for Use (Describe)
The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
The implants may be restored immediately
1) with a temporary prosthesis that is not in functional occlusion,
2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
- 3) for denture stabilization using multiple implants in the anterior mandible and maxilla.
The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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### 510(K) Summary
#### Submitter
Izenimplant Co., Ltd. Kwon, Mi-Kyung 1, 2Dong, 26-32, Suworam 4-Gil, Seotan-Myeon, Pyeongtaek-Si, Gyeonggi, 17703 Republic of Korea Email: mkkwon@izenimplant.com Tel. +82-31-662-0657 Fax. +82-31-662-0655
#### Official Correspondent
Withus Group Inc April Lee 106 Superior Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
#### Device Information
- . Trade Name: ZENEX Implant System Narrow
- Common Name: Endosseous Dental Implant
- . Classification Name: Implant, Endosseous, Root-Form
- Product Code: DZE
- . Secondary Product Code: NHA
- . Panel: Dental
- . Regulation Number: 872.3640
- . Date prepared: 07/28/2023
#### Predicate Devices:
The subject device is substantially equivalent to the following Devices:
Primary Predicate K161244, s-Clean OneQ-SL Narrow Implant System manufactured by Dentis Co., Ltd.
Reference Device
K161604, OSSTEM Implant System by Osstem Implant Co., Ltd.
K161987, UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure by DIO Corporation
K172100, URIS OMNI System by TruAbutment Korea Co.,Ltd.
K182081, JDentalCare Implant System JDIcon by J Dental Care S.R.L.
K182194, UV Active Implant System by DIO Corporation
K190849. IS-III active System S-narrow Type by Neobiotech Co., Ltd.
K211090, ZENEX Implant System by Izenimplant Co., Ltd.
K220079, Magicore Narrow System by InnobioSurg Co., Ltd.
#### Indications for Use
The ZENEX Implant System Narrow (3.0. 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
The implants may be restored immediately
1) with a temporary prosthesis that is not in functional occlusion,
2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
3) for denture stabilization using multiple implants in the anterior mandible and maxilla.
The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.
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#### Device Description:
The fixtures and abutments in this system are below:
1) Fixture
- . ZENEX MULTI Fixture
- . ZENEX PLUS Fixture
- 2) Abutment
- Cover Screw ●
- Healing Abutment
- Cemented Abutment (Hex, Non-Hex) ●
- Angled Abutment (Hex, Non-Hex)
- Temporary Abutment (Hex, Non-Hex) ●
- FreeMilling Abutment (Hex, Non-Hex)
- CCM Cast Abutment (Hex, Non-Hex) ●
- . Abutment Screw
An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The ZENEX Implant System Narrow consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations.
The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA(sand-blasted, large-grit, acid-etched).
| Fixture | Compatible<br>Abutment | Abutment<br>Diameter | Abutment Length (mm) | Abutment<br>Angle |
|-----------------------------------------------------------------|-------------------------|----------------------|-------------------------------------------------------------------------------------|-------------------|
| ZENEX<br>PLUS<br>Fixture<br>Ø 3.0<br>X<br>10, 11.5,<br>13, 15mm | Cover Screw | Ø2.6 | 4.0 | 0° |
| | Healing<br>Abutment | Ø4.0 | 7/8/9/10/11/13 | 0° |
| | Cemented<br>Abutment | Ø4.0 | Hex: 9.5/10.5/11.5/11/11.5/12/12.5/13/14<br>Non-Hex: 9/10/10.5/11/11.5/12/12.5/13.5 | 0° |
| | Angled<br>Abutment | Ø4.0 | Hex: 11/13<br>Non-Hex: 10.5/12.5 | 15° |
| | Temporary<br>Abutment | Ø4.0 | Hex: 13/15<br>Non-Hex: 12.5/14.5 | 0° |
| | FreeMilling<br>Abutment | Ø4.0 | Hex: 13/15<br>Non-Hex: 12.5/14.5 | 0° |
| | CCM Cast<br>Abutment | Ø4.0 | Hex: 13/15<br>Non-Hex: 12.5/14.5 | 0° |
ZENEX Plus Fixture is compatible with the subject abutments as below:
ZENEX MULTI Fixture is compatible with the abutments cleared in K211090 except cover screw as below:
| Fixture | Compatible<br>Abutment | Abutment<br>Diameter | Abutment Length (mm) | Abutment<br>Angle |
|---------------------------------------------|---------------------------------|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| ZENEX<br>MULTI<br>Fixture | Cover Screw<br>(Subject device) | Ø2.9/ Ø3.2 | 4.5/5.5/6.1 | 0° |
| | Healing Abutment | Ø4.3/ Ø4.8 | 7.5/8.5/9.5/11.5/13.5 | 0° |
| Ø 3.2<br>X<br>8.5, 10,<br>11.5, 13,<br>15mm | Cemented<br>Abutment | Ø4.0/ Ø4.5 | Hex:9.08/10.08/10.58/11.08/11.58/12.08/12.58/<br>13.08/13.58/14.08/14.58/15.08/15.58/16.08/16.58<br>Non-Hex:8.48/9.48/9.98/10.48/10.98/11.48/<br>11.98/12.48/12.98/13.48/13.98/14.48/14.98/15.98 | 0° |
| | Temporary<br>Abutment | Ø4.0 | Hex:13.58/15.58<br>Non-Hex: 12.98/14.98 | 0° |
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| Abutments | Uses | Surface Treatment |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Cover Screw | The cover Screw is used during the healing period prior to<br>restorations and maintain the shape of the gum | Non |
| Healing Abutment | The Abutment is used during the healing period prior to<br>restorations and maintain the shape of the gum. | Non |
| Cemented Abutment<br>(Hex, Non-Hex) | The Abutment is connected with fixture, and it supports<br>prosthesis which restores tooth function. | Partial TiN coated<br>in upper |
| Angled Abutment<br>(Hex, Non-Hex) | The Abutment is connected with fixture, and it supports<br>prosthesis which restores tooth function. | Partial TiN coated<br>in upper |
| Temporary Abutment<br>(Hex, Non-Hex) | The Abutment is used by removing the healing abutment as an<br>abutment for making temporary prostheses | Non |
| FreeMilling Abutment<br>(Hex, Non-Hex) | The Abutment is connected with fixture, and it supports<br>prosthesis which restores tooth function.<br>The FreeMilling Abutment is only intended to be modified by<br>hand-milling. | Partial TiN coated<br>in upper |
| CCM Cast Abutment<br>(Hex, Non-Hex) | It is used when there are restrictions on the prosthesis<br>production because of path, aesthetics, and space of fixture.<br>Production the prosthesis by casting with dental alloy after wax<br>up with desired shape | Non |
| Abutment Screw | Connection body to connect abutment to fixture. | Non |
Below are the abutment's features:
The subject fixture, cover screw and healing abutment are provided sterile.
Other abutments are provided non-sterile and packaged separately. The abutments should be sterilized before use by End User sterilization.
### Materials:
- ZENEX Implant Narrow Fixtures and abutments are made of Ti-6Al-4V Eli
- -CCM Cast Abutment is made of Co-Cr-Mo Alloy
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# K230630
## Summaries of Technological Characteristics & Substantial Equivalence Discussion
## Fixture – ZENEX MULTI Fixture and ZENEX PLUS Fixture
| | Subject Device | Primary Predicate | Reference Device | Reference Device |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Izenimplant Co.,Ltd | Dentis Co., Ltd. | InnoBioSurg Co.,Ltd | Neobiotech Co., Ltd |
| Product Name | ZENEX Implant | s-Clean OneQ-SL Narrow | Magicore Narrow System | IS-III active System_ |
| | System_Narrow | Implant System | | S-Narrow Type |
| 510(K) # | K230630 | K161244 | K220079 | K190849 |
| Classification | Class II | Class II | Class II | Class II |
| Design | Image: ZENEX Implant System_Narrow Design | Image: s-Clean OneQ-SL Narrow Implant System Design | Image: Magicore Narrow System Design | Image: IS-III active System_S-Narrow Type Design |
| Connection | Internal Hex | Internal Hex | Internal Hex | Internal Hex |
| Endosseous<br>Implant | Tapered, macro threads | Tapered, macro threads | Tapered, macro threads | Tapered, macro threads |
| Surgical<br>Technique | 1 and 2 stage, self-tapping | 1 and 2 stage, self-tapping | 1 and 2 stage, self-tapping | 1 and 2 stage, self-tapping |
| Diameter and<br>Length(mm) | • Ф3.0mm<br>X10,11.5,13,15 mm | Ф3.0, 3.3mm X10,12,14mm | Ф3.0mm<br>11,13,15mm | Ф3.2mm<br>8.5/10.0/11.5/13.0/15.0 |
| | • Ф3.2mm X<br>8.5,10,11.5,13,15 mm | | | |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Surface | Sandblasted and acid-etched | Sandblasted and acid-etched | Sandblasted and acid-etched | Sandblasted and acid-etched |
| Sterilization | Radiation | Radiation | Radiation | Radiation |
| Shelf life | 5 years | 8 years | 8 years | 5 years |
| Indications for<br>use | The ZENEX Implant<br>System_Narrow (3.0,<br>3.2mm) may be used as an<br>artificial root structure for | The s-Clean OneQ-SL Narrow<br>Implant System (3.0, 3.3mm)<br>may be used as an artificial<br>root structure for single tooth | The Magicore Narrow System<br>(3.0, 3.5mm) may be used as an<br>artificial root structure for single<br>tooth replacement of mandibular | The IS-III active System_S-<br>narrow Type is indicated for use<br>in surgical and restorative<br>applications for placement in the |
| | single tooth replacement of<br>mandibular central and<br>lateral incisors and<br>maxillary lateral incisors.<br>The implants may be<br>restored immediately | replacement of mandibular<br>central and lateral incisors and<br>maxillary lateral incisors.<br>The implants may be restored<br>immediately<br>1) with a temporary prosthesis<br>that is not in functional<br>occlusion, | central and lateral incisors and<br>maxillary lateral incisors.<br>The implants may be restored<br>immediately<br>1) with a temporary prosthesis<br>that is not in functional occlusion,<br>2) when splinted together as an<br>artificial root structure for | mandibular central, lateral<br>incisor and maxillary lateral<br>incisor regions of partially<br>edentulous jaws where the<br>horizontal space is limited by the<br>adjacent teeth and roots, to<br>provide support for prosthetic<br>devices, such as artificial teeth, |
| | 1) with a temporary<br>prosthesis that is not in<br>functional occlusion,<br>2) when splinted together as<br>an artificial root structure for<br>multiple tooth replacement<br>of mandibular incisors, or<br>3) for denture stabilization<br>using multiple implants in<br>the anterior mandible and<br>maxilla.<br>The implants may be placed<br>in immediate function when<br>good primary stability has<br>been achieved and with<br>appropriate occlusal loading. | 2) when splinted together as an<br>artificial root structure for<br>multiple tooth replacement of<br>mandibular incisors, or<br>3) for denture stabilization<br>using multiple implants in the<br>anterior mandible and maxilla.<br>The implants may be placed in<br>immediate function when good<br>primary stability has been<br>achieved and with appropriate<br>occlusal loading. | multiple tooth replacement of<br>mandibular incisors, or<br>3) for denture stabilization using<br>multiple implants in the anterior<br>mandible and maxilla.<br>The implants may be placed in<br>immediate function when good<br>primary stability has been<br>achieved and with appropriate<br>occlusal loading. | in order to restore the patient's<br>chewing function.<br>The IS-III active System_S-<br>narrow Type is indicated also for<br>immediate loading when good<br>primary stability is achieved and<br>with appropriate occlusal<br>loading. |
| SE Discussion | The ZENEX Implant System_Narrow has similar device characteristics with the Primary predicate, K161244 such as intended use,<br>functions, material, surface treatment, fixture diameter, structure and applied production method.<br>The difference between the subject device and primary predicate are device design, 15mm length fixtures, Ø3.2X8.5mm and shelf life.<br>The difference of the device design of both device's fundamental functions and safety. To support the 15mm<br>length for each diameter, K220079 and K190849 were added as reference device. To support the difference of the Ø3.2X8.5mm and<br>shelf life, the K190849 was added.<br>Any differences do not raise different questions of safety and effectiveness than the primary predicate; therefore, it is substantial<br>equivalent. | | | |
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# Abutment
## 1) Cover Screw
| | | Subject Device | Reference Device |
|----------------|-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Manufacturer | | Izenimplant Co.,Ltd | Izenimplant Co.,Ltd |
| Product Name | | ZENEX Implant System_Narrow | ZENEX Implant System |
| 510(K) Number | | K230630 | K211090 |
| Classification | | Class II | Class II |
| Design | | Image: Subject Device Design | Image: Reference Device Design |
| | D | $Φ2.6~3.2$ | $Φ3.0~3.9$ |
| Dimension | L | 4~6.1mm | 5~7.3mm |
| | Angle | 0° | 0° |
| Material | | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Surface | | Non-Coating | Non-Coating |
| Sterilization | | Radiation | Radiation |
| Shelf life | | 5 years | 5 years |
| SE Discussion | | The subject device is similar in intended use, fundamental scientific technology, principle<br>of operation, general design, technology, functions, and materials with the identified<br>reference device, K211090.<br>The difference between the subject and reference device is dimension of the device.<br>However, it does not affect device's fundamental functions and safety; therefore, it is<br>substantial equivalent. | |
## 2) Healing Abutment
| | Subject Device | Reference Device | Reference Device | |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------------|-----------|
| Manufacturer | Izenimplant Co.,Ltd | Izenimplant Co.,Ltd | Osstem Implant Co., Ltd | |
| Product Name | ZENEX Implant<br>System_Narrow | ZENEX Implant System | Osstem Implant System | |
| 510(K) Number | K230630 | K211090 | K161604 | |
| Classification | Class II | Class II | Class II | |
| Design | | | | |
| Dimension | D | Φ4.0 | Φ4.3~9.0 | Φ4.0 |
| | P/H | 3.0~9.0mm | 2.0~9.0mm | 3.0~9.0mm |
| | Angle | 0° | 0° | 0° |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| Surface | Non-Coating | Non-Coating | TiN Coating | |
| Sterilization | Radiation | Radiation | Radiation | |
| Shelf life | 5 years | 5 years | 5 years | |
| SE Discussion | The subject device is similar in intended use, fundamental scientific technology, principle of operation, general design, technology, functions, and materials with the identified reference device, K161604. | | | |
| | The difference between the subject and reference device, K161604 is surface treatment. To support the discrepancy, K211090 was added. Therefore, it is substantial equivalent | | | |
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## 3) Cemented Abutment
| | Subject Device | Reference Device | |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|------------|
| Manufacturer | Izenimplant Co.,Ltd | Neobiotech Co., Ltd | |
| Product Name | ZENEX Implant System_Narrow | IS-III active System_S-Narrow Type | |
| Abutment Name | Cemented Abutment | IS Shapable Abutment | |
| 510(K) Number | K230630 | K190849 | |
| Classification | Class II | Class II | |
| Design | Image: Hex design of subject device<br>Image: Non-Hex design of subject device | Image: Hex design of reference device<br>Image: Non-Hex design of reference device | |
| Dimension | D | $Φ4.0$ | $Φ3.5/4.0$ |
| | G/H | 2.0-5.0mm | 2.0-5.0mm |
| | P/H | 5.5/7.0mm | 5.5/7.0mm |
| | Angle | 0° | 0° |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| Surface | Partial TiN coated in upper | Partial TiN coated in upper | |
| Sterilization | End User Sterilization | End User Sterilization | |
| SE Discussion | The subject device is similar in intended use, fundamental scientific technology, principle of operation, general design, technology, functions, dimension and materials with the identified reference device, K190849.<br>The design of the subject and reference device is slightly different. However, it does not affect device's fundamental functions and safety; therefore, it is substantial equivalent. | | |
## 4) Angled Abutment
| | | Subject Device | | Reference Device | |
|----------------|-------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------------|---------|
| Manufacturer | | Izenimplant Co.,Ltd | | DIO Corporation | |
| Product Name | | ZENEX Implant System_Narrow | | UV Active Implant System | |
| 510(K) Number | | K230630 | | K182194 | |
| Classification | | Class II | | Class II | |
| Design | | | |…
