INCLUSIVE TAPERED IMPLANT SYSTEM
Device Facts
| Record ID | K153099 |
|---|---|
| Device Name | INCLUSIVE TAPERED IMPLANT SYSTEM |
| Applicant | Prismatik Dentalcraft, Inc. |
| Product Code | DZE · Dental |
| Decision Date | May 23, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Inclusive Tapered Implant System is indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.
Device Story
Inclusive Tapered Implant System consists of threaded, root-form endosseous dental implants, abutments, and fixation screws. Implants are manufactured from Grade 23 titanium alloy (Ti-6Al-4V ELI) with a hydroxyl apatite-blasted and acid-etched surface. The 3.2mm diameter implant features a 6-point flower internal connection. Used by dental professionals in clinical settings to replace missing teeth. Implants are provided sterile via gamma radiation; abutments and screws are provided non-sterile for chairside sterilization. The device supports prosthetic rehabilitation by providing a stable foundation for restorations. Clinical benefit includes restoration of dental function and aesthetics in edentulous patients.
Clinical Evidence
Bench testing only. Performance data included fatigue testing and static load failure testing of finished assembled implant/abutment systems per ISO 14801:2007 and FDA guidance for root-form endosseous dental implants. No clinical data was required or provided.
Technological Characteristics
Material: Titanium alloy Grade 23 (ASTM F136). Design: Threaded root-form, internal 6-point flower connection. Surface: Hydroxyl apatite-blasted and acid-etched. Sterilization: Gamma radiation (implants/healing abutments); steam sterilization (abutments/screws). Standards: ISO 10993-1, ISO 14971, ISO 14801, ASTM F136, ANSI-AAMI ST79, ISO 17665-1, ISO 11137.
Indications for Use
Indicated for maxillary and mandibular partially or fully edentulous patients requiring single, multiple-unit, or overdenture restorations. Contraindicated for cases lacking primary stability or appropriate occlusal loading conditions.
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
- Inclusive Tapered Implant System (K121406)
Reference Devices
- Hahn Tapered Implant System (K143353)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2016
Prismatik Dentalcraft, Inc. Ms. Maria E. Wagner Sr. Specialist, Regulatory Affairs 2212 Dupont Drive, Suite P Irvine, California 92612
Re: K153099
Trade/Device Name: Inclusive® Tapered Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 4, 2016 Received: May 5, 2016
Dear Ms. Wagner:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
-s
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K153099
Device Name Inclusive® Tapered Implant System
## Indications for Use (Describe)
Inclusive Tapered Implant System is indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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# 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 Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
B.
# 007_510 (K) Summary-807.92
This 510 (k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
## A. SUBMITTER INFORMATION
| Company Name: | Prismatik Dentalcraft, Inc. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Company Address: | 2212 Dupont Dr., Suite P,<br>Irvine, CA 92612 |
| Company Phone: | 949-440-2636 |
| Company FAX: | 949-553-0924 |
| Facility Registration Number: | 2031503 |
| Primary Contact Person: | Maria Wagner, (949) 440-2636<br>Senior Specialist, Regulatory Affairs<br>Maria.wagner@glidewelldental.com |
| Secondary Contact Person | Shelly Harris, (949) 440-2629<br>Director of Regulatory Affairs & Quality<br>Assurance<br>Shelly.harris@glidewelldental.com |
| Date Summary Prepared: | May 18, 2016 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary Name: | Inclusive® Tapered Implant System |
| 21 CFR Reference: | 21 CFR 872.3640 |
| 21 CFR Common Name: | Endosseous dental implant |
| Classification: | Class II, DZE, NHA |
| Panel: | Dental |
## C. IDENTIFICATION OF PREDICATE DEVICE
| Primary Predicate: | Inclusive Tapered Implant System (K121406, Cleared on 2/22/2013) |
|----------------------|------------------------------------------------------------------|
| Reference Predicate: | Hahn Tapered Implant System (K143353, Cleared on 4/2/2015) |
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Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with different colors inside. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", in blue text.
### PROPOSED DEVICE DESCRIPTION D.
The proposed device, Inclusive® Tapered Implant System, is manufactured from biocompatible Titanium alloy. The implant is designed with an internal hex connection with a diameter of implant with a 6-point flower (drawings are provided in the table below). Equipped with a tapered body and used to replace one or more missing teeth. The surface is blasted with Hydroxyl Apatite and acid etched. The dental implant (proposed device) will be provided sterile using gamma sterilization. The Inclusive Tapered Implant System, includes abutments in the form of healing abutments, engaging and non-engaging temporary abutments, straight and angled titanium abutments, titanium abutment fixation screws and straight multi-unit abutments.
### E. INDICATIONS FOR USE
Inclusive® Tapered Implant System is indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.
### F. DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The comparison table below outlines and provides the similarities and the substantial equivalency of the proposed device, the Inclusive® Tapered Implant System, to the predicate device, Inclusive® Tapered Implant System, K121406. Prismatik believes that the comparative data presented in the preceding paragraphs demonstrate that the proposed device is essentially the same as currently marketed devices for the same indications for use, same materials same fundamental scientific technology and design and supports our claim of substantial equivalence to predicate Class II devices under the classification of endosseous dental implant (21 CFR 872.3640) that have previously been found to be substantially equivalent. Any differences between the proposed device and the predicate device does not introduce new concerns in safety and efficacy.
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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
| Attributes | Predicate Device | Referenced Device | Proposed Device | Similarities and<br>Differences |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| | Inclusive Tapered Implant<br>System (K121406) | Hahn Tapered Implant<br>System (K143353) | Inclusive Tapered Implant -<br>3.2 implant | |
| Picture of<br>Implant | Image: Inclusive Tapered Implant System (K121406) | Image: Hahn Tapered Implant System (K143353) | Image: Inclusive Tapered Implant - 3.2 implant | Same as<br>Predicate |
| Indications for<br>Use | Inclusive Tapered Implants are<br>indicated for use in maxillary<br>and mandibular partially or<br>fully edentulous cases, to<br>support single, multiple-unit,<br>and overdenture restorations.<br>The implants are to be used for<br>immediate loading only in the<br>presence of primary stability<br>and appropriate occlusal<br>loading. | Hahn Implants are indicated<br>for use in maxillary and<br>mandibular partially or fully<br>edentulous cases, to support<br>single, multiple-unit, and<br>overdenture restorations. The<br>implants are to be used for<br>immediate loading only in the<br>presence of primary stability<br>and appropriate occlusal<br>loading. | Inclusive Tapered Implant<br>System is indicated for use in<br>maxillary and mandibular<br>partially or fully edentulous<br>cases, to support single,<br>multiple-unit, and overdenture<br>restorations. The implants are to<br>be used for immediate loading<br>only in the presence of primary<br>stability and appropriate occlusal<br>loading. | Same |
| Surface | Blasted with Hydroxyl<br>Apatite and acid etched | Blasted with Hydroxyl<br>Apatite and acid etched | Blasted with Hydroxyl Apatite<br>and acid etched | Same |
| Connection | Image: Connection 3.7 - 5.2: Internal Hex | Image: Connection 3.0: 6-point flower<br>3.5-7.0: Internal Hex | Image: Connection 3.2: 6-point flower | Same as<br>reference |
| Design | Threaded root-form implant | Threaded root-form implant | Threaded root-form implant | Same |
| Implant Body<br>Geometry | Screw Type | Screw Type | Screw Type | Same |
| Diameters<br>(mm) | 3.7, 4.7, 5.2 | 3.0, 3.5, 4.3, 5.0, 7.0 | 3.2 | New: Additional<br>Size |
| Lengths (mm) | 3.7 - 5.2: 8, 10, 11.5, 13 & 16 | 3.0: 11.5, 13 & 16<br>3.5 - 5.0: 8, 10, 11.5, 13 & 16<br>7.0: 8, 10 & 11.5 | 3.2: 11.5, 13, and 16 | Same |
| Attributes | Predicate Device | Referenced Device | Proposed Device | Similarities and<br>Differences |
| | Inclusive Tapered Implant<br>System (K121406) | Hahn Tapered Implant<br>System (K143353) | Inclusive Tapered Implant -<br>3.2 implant | |
| Sterility | Packaged Sterile | Packaged Sterile | Packaged Sterile | Same |
| Material | Titanium Alloy, Grade 23 | Titanium Alloy, Grade 23 | Titanium Alloy, Grade 23 | Same |
| Description of<br>Abutment | Titanium abutments are made<br>from titanium alloy. Titanium<br>Abutments are prefabricated<br>prosthetic components<br>directly connected to<br>endosseous dental implants<br>and are intended to use as an<br>aid to prosthetic rehabilitation. | Titanium abutments are made<br>from, titanium alloy. Titanium<br>Abutments are prefabricated<br>prosthetic components<br>directly connected to<br>endosseous dental implants<br>and are intended to use as an<br>aid to prosthetic<br>rehabilitation. | Titanium abutments are made<br>from the same material, titanium<br>alloy, Titanium Abutments are<br>prefabricated prosthetic<br>components directly connected<br>to endosseous dental implants<br>and are intended to use as an aid<br>to prosthetic rehabilitation. | Same |
| Picture of<br>Screw | Image: Screw | Image: Screw | Image: Screw | Same as<br>reference |
| Abutment<br>Angle | 0°-20° | 0°-30° | 0°-15° | within range of<br>previous<br>clearances |
| Description of<br>Change | None | None | Addition of the 3.2 - External<br>thread pattern of the Inclusive<br>Implant combined with internal<br>connection of the Hahn 3.0<br>(reference). | Additional size<br>3.2 mm |
| Abutment<br>Seat | Image: Abutment Seat | Image: Abutment Seat | Image: Abutment Seat | Same as<br>reference |
| Attributes | Predicate Device | Referenced Device | Proposed Device | Similarities and<br>Differences |
| | Inclusive Tapered Implant<br>System (K121406) | Hahn Tapered Implant<br>System (K143353) | Inclusive Tapered Implant -<br>3.2 implant | |
| Screw Seat | Sits on a flat | Sits on a taper | Sits on a Taper | Same as<br>reference |
| Construction | Machined | Machined | Machined | Same |
# Table 1 – Comparison between Predicate and Proposed Device
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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangular prism on the left and the company name on the right. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
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Image /page/7/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of two parts: a colorful triangular prism on the left and the company name on the right. The prism is divided into multiple sections, each filled with a different color, creating a rainbow effect. The text "PRISMATIK DENTALCRAFT, INC." is written in a bold, sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
#### G. SUMMARY OF NON-CLINICAL TESTING (PERFORMANCE DATA)
Non-clinical test data was used to support the substantial equivalency. The functionality of the proposed Inclusive® Tapered Implant System, 3.2 as well as their conformance to design input was further determined by performance testing (Fatigue Testing and Static Load Failure Testing of finished assembled implant/abutment systems). The testing was performed in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing performed demonstrated implant to abutment compatibility. The applicable standards that are used in this submission are listed below:
| Applicable Standards | |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1: 2009 | Biological Evaluation of Medical Devices-<br>Evaluation and testing |
| ISO 14971: 2012 | Medical Devices —Application of risk<br>management to medical devices |
| ASTM F136-13: 2013 | Standard for Wrought Titanium-6Aluminum-<br>4Vanadium ELI (Extra Low Interstitial) Alloy for<br>Surgical Implant Applications |
| ISO 14801:2007 | Dentistry - Implants - Dynamic fatigue test for<br>endosseous dental implants |
| BS EN 1641:2009 | Dentistry — Medical devices for dentistry —<br>Materials |
| ANSI-AAMI ST79: 2010 & A1: 2010<br>& A2: 2011 & A3: 2012 | Comprehensive guide to steam sterilization and<br>sterility assurance in health care facilities |
| ISO 17665-1:2006 | Sterilization of health care products — Moist<br>heat — Part 1: Requirements for the<br>development, validation and routine control of a<br>sterilization process for medical devices |
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Image /page/8/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into sections of different colors, including pink, blue, and yellow. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
| ISO 11137-1:2006+A: 2013 | Sterilization of health care products - Radiation -<br>Part 1: Requirements for development,<br>validation and routine control of a sterilization<br>process for medical devices |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 11137-2:2013 | 2013 Sterilization of health care products —<br>Radiation Part 2: Establishing the sterilization |
The proposed Inclusive® Tapered Implant System, 3.2 is manufactured from biocompatible titanium grade 23 (Ti-6AL-4V ELI) and meets ASTM F-136 Standard. In accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", in lieu of performing biocompatibility testing per ISO 10993-1 for the subject device, we have identified a Prismatik predicate device and a Prismatik reference device with identical materials, same manufacturing process, and same type/duration of patient contact:
- . -P r i m a r y Predicate: K121406, Inclusive Tapered Implant System
- . -Reference Predicate: K143353, Hahn Tapered Implant System
The proposed device, the Inclusive® Tapered Implant System, 3.2 consists of dental implants, abutments, and screws. The implant, healing abutments, and multi-unit abutments will be provided sterile. Abutments and fixation screws are provided non-sterile and sterilized prior to use. The sterilization and shelf life of all components of the device are supported by prior validation conducted for the applicant's own primary and reference predicate devices K121406 and K143353
### CONCLUSION FROM THE NON-CLINICAL TESTING (PERFORMANCE DATA) H.
The proposed device, the Inclusive® Tapered Implant System has the same performance specifications, fundamental scientific technology and intended use as that of the predicate device, Inclusive® Tapered Implant System, K121406 (Clearance letter dated February 22, 2013) and the reference device Hahn Tapered Implant System, K143353 (Clearance letter dated April 2, 2015). The performance data and a declaration of conformity with design controls supports a determination of continuing substantial equivalence of the proposed device to the predicate and referenced devices.
