(206 days)
Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact™ Dental Implant System 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.
All digitally designed Kontact™ Dental Implant System CAD/CAM abutments are intended to be sent to a Biotech Dental validated milling center for manufacture.
The purpose of this submission is to expand the marketing clearance for Kontact™ Dental Implant System which comprises endosseous root-form dental implants and prosthetic components for single-unit, multi-unit, and overdenture restorations to include two additional implant body designs, new Narrow Conical and Conical abutments, hand-milled FitPost abutments, inserts for the previously cleared UniPost abutments and CAD/CAM Titanium base and Titanium Blank, dental implant abutments.
The Kontact™ Dental Implant System Subject device include two implant designs: Kontact S+. The Kontact S and compatible Kontact implants are provided in five body diameters: 3.0 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The body diameter for each implant is equal to the implant platform diameter. The 3.0 mm body implants have a smaller diameter and unique restorative interface. The 3.6 mm, 4.8 mm, and 5.4 mm implants share the same restorative interface. The Kontact S implants are provided in lengths ranging from 8 mm to 16 mm.
The Kontact S+ implants are provided in four body diameters: 4.0 mm, 4.5 mm, 5.0 mm, and 5.5 mm. The 4.0 mm body diameter implants have an implant platform diameter of 3.6 mm and 5.5 mm body diameter implants have an implant platform diameter of 4.2 mm diameter implants are available in both 3.6 mm and 4.2 mm implant platform diameters. All Kontact S+ implants share restorative interface as the 3.6 mm and larger diameter Kontact S implants. The Kontact S+ implants are provided in lengths ranging from 8 mm to 12 mm.
The implants have a recessed internal section for abutment indexing, and an internal threaded section for mating to the corresponding subject device cover screw, or abutment screw. Kontact S and Kontact S+ implants are manufactured from Commercially Pure (CP) – Grade 4 titanium conforming to ASTM F67 and ISO 5832-2. The endosseous threaded surface of the Kontact S+ implants are gritblasted with resorbable beta-tricalcium phosphate (β-ΤCP) particles.
Grit-blasting of the Kontact S+ implants create a roughened surface which provides an increase in total contact area of the implant surface to facilitate osseointegration.
The Subject device prosthetic components include seven implant abutment designs: Straight Conical, 30° Angulated Conical (indexed and non-indexed), Titanium Base, Titanium Blank and FitPost. The abutments designs are compatible with the Kontact, Kontact S+ implants. All Subject device abutments are manufactured titanium alloy conforming to ASTM F136 and ISO 5832-3.
The provided document describes the K213997 Kontact Dental Implant System. This premarket notification primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and literature review, rather than establishing performance criteria against specific clinical endpoints with a device that provides diagnostic information. Therefore, the typical structure for acceptance criteria and a study proving a device meets these criteria for an AI/ML diagnostic or prognostic device is not directly applicable.
However, I can extract the relevant information from the document to describe how the manufacturer demonstrated that their device met the safety and performance requirements for a dental implant system.
Here's the information organized based on your request, with adaptations for a non-diagnostic medical device:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (dental implant system), "acceptance criteria" are generally derived from recognized standards for biocompatibility and mechanical performance, and "reported device performance" refers to the results of non-clinical testing against these standards, as well as a review of clinical outcomes from a published study on similar implants.
| Acceptance Criteria (Relevant Standards/Benchmarks) | Reported Device Performance |
|---|---|
| Biocompatibility: In accordance with ISO 10993-1, including Cytotoxicity (ISO 10993-5:2009) and Endotoxins (ANSI/AAMI ST72:2019). | Cytotoxicity: Performed and results were satisfactory. Endotoxins: Performed and results were satisfactory. Overall Biocompatibility: Evaluated through published literature, internal routine monitoring data, and post-market surveillance data on implants made from the same material and surface treatment, indicating "failure rates below industry levels." |
| Mechanical Performance: Static compression and compression fatigue testing according to ISO 14801 (worst-case constructs). | ISO 14801 Testing: Performed on worst-case constructs of the Subject device (covering implant platform, gingival height, and post correction angles combinations). Results demonstrated suitability for intended use, mitigating minor differences in designs, dimensions, or sizes compared to predicate/reference devices. |
| Sterilization: Steam Sterilization according to ISO 17665-1 and ISO TS 17665-2. | Steam Sterilization: Protocols leveraged from the prior K210220 Primary Predicate device clearance, indicating compliance. |
| MRI Safety Assessment: Parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (magnetically induced displacement force and torque). | MRI Safety Assessment: Non-clinical worst-case MRI review performed using scientific rationale and published literature (e.g., Woods et al., 2019). The rationale addressed parameters for the entire system (all compatible implant bodies, abutments, and fixation screws) and material composition, demonstrating adequate safety in the MR environment. |
| Clinical Performance (Indirect): Acceptable bone-level changes and implant survival rates in a clinical context (benchmarked against industry standards). | Published Retrospective Study: Evaluated bone levels of 326 implants, showing decreases less than 1 mm ("well within accepted levels") through 50 months post-implantation, with an overall implant survival rate of 98% at 1 year. (This study was not performed by the submitter for this clearance but was leveraged as part of the biological evaluation and demonstration of clinical performance of similar implants). |
2. Sample Size Used for the Test Set and Data Provenance
For the non-clinical tests:
- Biocompatibility: The specific sample sizes for cytotoxicity and endotoxin tests are not individually stated but are implied to be sufficient per the referenced ISO and ANSI/AAMI standards.
- Mechanical Performance (ISO 14801): The sample size refers to "worst-case constructs," implying a selection of implant and abutment combinations designed to represent the most challenging scenarios for mechanical failure. The exact number is not explicitly stated.
- Data Provenance: The mechanical performance and sterilization data are from non-clinical bench testing conducted by the manufacturer. The biocompatibility evaluation also involved internal routine monitoring data.
For the leveraged clinical performance:
- Sample Size: 326 implants were evaluated in a published multi-center retrospective study.
- Data Provenance: This was a retrospective study. The country of origin is not specified, but it was a "multi-center" study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not directly applicable as this submission is not for an AI/ML diagnostic device requiring expert-established ground truth for a test set. The "ground truth" for this dental implant system is primarily established by:
- Compliance with recognized international standards (ISO, ANSI/AAMI): These standards define acceptable material properties and mechanical performance.
- Observation of physical outcomes in non-clinical bench tests: Mechanical integrity, sterilization efficacy, and MRI compatibility are directly measured.
- Leveraged Clinical Literature: The multi-center retrospective study (not conducted by the submitter) provides clinical outcome data (bone level changes, survival rate) for similar implants. The experts involved in that study (e.g., dentists, surgeons, researchers) would have established the "ground truth" of patient outcomes, though no specific number or qualifications are provided in this submission for that study.
4. Adjudication Method for the Test Set
Not applicable in the context of an AI/ML diagnostic or prognostic device with human adjudication. The "adjudication" for this device involves applying the results of the non-clinical tests (e.g., pass/fail for mechanical loads, conformity to biocompatibility limits) against the requirements of the referenced standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a dental implant system, not a diagnostic imaging device with AI assistance for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (dental implant system), not an algorithm.
7. The Type of Ground Truth Used
- Non-clinical Testing: The ground truth for mechanical performance, sterility, and MRI safety is established by direct measurement and observation against predefined criteria in recognized scientific and engineering standards (e.g., force limits, microbial kill rates, magnetic susceptibility properties).
- Biocompatibility: Established by adherence to ISO 10993 standards for various biological endpoints, alongside review of existing data.
- Clinical Outcomes Data (leveraged): For the indirect clinical performance evaluation, the ground truth was based on clinical outcomes (bone-level changes, implant survival rates) derived from a published multi-center retrospective study.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The design and manufacturing processes are informed by engineering principles, material science, and prior predicate device data, rather than machine learning on a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The words "U.S. FOOD & DRUG" are stacked on top of the word "ADMINISTRATION".
7/15/22
Biotech Dental, SAS % Chris Brown Manager Aclivi, LLC 3250 Brackley Drive Ann Arbor. Michigan 48105
Re: K213997
Trade/Device Name: Kontact Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 9, 2022 Received: June 13, 2022
Dear Chris Brown:
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 Andrew 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213997
Device Name Kontact™Dental Implant System
Indications for Use (Describe)
Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact™ Dental Implant System 3 mm diameter implants and prosthetics components are in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.
All digitally designed Kontact™ Dental Implant System CAD/CAM abutments are intended to be sent to a Biotech Dental validated milling center for manufacture.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
C)
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510(k) Summary K213997 Biotech Dental Kontact™ Dental Implant System 7/15/2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Biotech Dental, SAS305, Allées de Craponne13300 Salon de Provence |
|---|---|
| Telephone: | +33 04 90 44 60 60 |
| Fax: | +33 04 90 44 60 61 |
| Official Contact: | Delphine Mercier, VP Compliance |
| Email: | d.mercier@biotech-dental.com |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/Proprietary Name: | Kontact™ Dental Implant System |
| Common Name: | Implant, Dental, Endosseous, Root-Form |
| Classification Name: | Endosseous dental implant |
| Classification Regulation: | 21 CFR 872.3640 |
| Device Class: | Class II |
| Product Code: | DZE, NHA |
| Review Panel: | Dental Products Panel |
| Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1B)Dental Devices (DHT1B) |
PREDICATE DEVICE INFORMATION
The devices within this submission are the same or highly similar in indications, intended use and design principles to the following Primary Predicate device:
| 510(k) | Primary Predicate Device Name | Company Name |
|---|---|---|
| K210220 | Kontact™ Dental Implant System | Biotech Dental, SAS |
| 510(k) | Reference Device Name | Company Name |
| K122300 | 3i T3 Dental Implant | BIOMET 3i |
Medentika GmbH
TruAbutment Inc.
Medentika CAD/CAM Abutments
URIS OMNI Narrow System & Prosthetic
INDICATIONS FOR USE
Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact™ Dental Implant System 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.
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All digitally designed Kontact™ Dental Implant System CAD/CAM abutments are intended to be sent to a Biotech Dental validated milling center for manufacture.
DEVICE DESCRIPTION
The purpose of this submission is to expand the marketing clearance for Kontact™ Dental Implant System which comprises endosseous root-form dental implants and prosthetic components for single-unit, multi-unit, and overdenture restorations to include two additional implant body designs, new Narrow Conical and Conical abutments, hand-milled FitPost abutments, inserts for the previously cleared UniPost abutments and CAD/CAM Titanium base and Titanium Blank, dental implant abutments.
The Kontact™ Dental Implant System Subject device include two implant designs: Kontact S+. The Kontact S and compatible Kontact implants are provided in five body diameters: 3.0 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The body diameter for each implant is equal to the implant platform diameter. The 3.0 mm body implants have a smaller diameter and unique restorative interface. The 3.6 mm, 4.8 mm, and 5.4 mm implants share the same restorative interface. The Kontact S implants are provided in lengths ranging from 8 mm to 16 mm.
The Kontact S+ implants are provided in four body diameters: 4.0 mm, 4.5 mm, 5.0 mm, and 5.5 mm. The 4.0 mm body diameter implants have an implant platform diameter of 3.6 mm and 5.5 mm body diameter implants have an implant platform diameter of 4.2 mm diameter implants are available in both 3.6 mm and 4.2 mm implant platform diameters. All Kontact S+ implants share restorative interface as the 3.6 mm and larger diameter Kontact S implants. The Kontact S+ implants are provided in lengths ranging from 8 mm to 12 mm.
The implants have a recessed internal section for abutment indexing, and an internal threaded section for mating to the corresponding subject device cover screw, or abutment screw. Kontact S and Kontact S+ implants are manufactured from Commercially Pure (CP) – Grade 4 titanium conforming to ASTM F67 and ISO 5832-2. The endosseous threaded surface of the Kontact S+ implants are gritblasted with resorbable beta-tricalcium phosphate (β-ΤCP) particles.
Grit-blasting of the Kontact S+ implants create a roughened surface which provides an increase in total contact area of the implant surface to facilitate osseointegration.
| ImplantType | Implant BodyDiameter (mm) | Implant PlatformDiameter (mm) | Lengths (mm) |
|---|---|---|---|
| Kontact S | Ø 3.0 | Ø 3.0 | 10, 12, 14 |
| Ø 3.6 | Ø 3.6 | 8, 10, 12, 14, 16 | |
| Ø 4.2 | Ø 4.2 | 8, 10, 12, 14, 16 | |
| Ø 4.8 | Ø 4.8 | 8, 10, 12, 14 | |
| Ø 5.4 | Ø 5.4 | 8, 10, 12, 14 | |
| Kontact S+ | Ø 4.0 | Ø 3.6 | 8, 10, 12 |
| Ø 4.5 | Ø 3.6 | 8, 10, 12 | |
| Ø 4.5 | Ø 4.2 | 8, 10, 12 | |
| Ø 5.0 | Ø 4.2 | 8, 10, 12 | |
| Ø 5.5 | Ø 4.2 | 8, 10, 12 |
Kontact™ Dental Implant System - Kontact S and Kontact S+ Implant Sizes
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The Subject device prosthetic components include seven implant abutment designs: Straight Conical, 30° Angulated Conical (indexed and non-indexed), Titanium Base, Titanium Blank and FitPost. The abutments designs are compatible with the Kontact, Kontact S+ implants. All Subject device abutments are manufactured titanium alloy conforming to ASTM F136 and ISO 5832-3. The Subject device prosthetic components are summarized in the following tables.
| Subject Device Abutment Designs for Kontact S Implants | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ImplantDiameterKontact S(mm) | ImplantPlatformDiameterKontact S(mm) | ProstheticInterface(implant/abutment)Diameter(mm) | StraightNarrowConicalMulti-Unit | 30° Angulated NarrowConical and ConicalMulti-Unit | 30° AngulatedConicalMulti-Unit | Titanium Base(CAD/CAM) | TitaniumBlank(CAD/CAM) | FitPost(Hand Milled) | Screws* | |
| (non-indexed) | (indexed) | (non-indexed) | ||||||||
| 3.0 | 3.0 | 2.49 | n/a | n/a | n/a | X | X | n/a | X | |
| 3.6 | 3.6 | 2.89 | X | X | X | X | X | X | X | |
| 4.2 | 4.2 | 2.89 | X | X | X | X | X | X | X | |
| 4.8 | 4.8 | 2.89 | X | X | X | X | X | X | X | |
| 5.4 | 5.4 | 2.89 | X | X | X | X | X | X | X | |
| Material | Grade 5 - Titanium | |||||||||
| Finish | None | Blue Anodize | None | Yellow Anodize | None | None | None |
Kontact™ Dental Implant System – Prosthetic Components
| ImplantDiameterKontact S+(mm) | ImplantPlatformDiameterKontact S+(mm) | ProstheticInterface(implant/abutment)Diameter(mm) | StraightNarrowConicalMulti-Unit | 30° Angulated NarrowConical and ConicalMulti-Unit | 30° AngulatedConicalMulti-Unit | Titanium Base(CAD/CAM) | TitaniumBlank(CAD/CAM) | FitPost(Hand Milled) | Screws* |
|---|---|---|---|---|---|---|---|---|---|
| Image: Straight Narrow Conical Multi-Unit (non-indexed) | Image: 30° Angulated Narrow Conical and Conical Multi-Unit (indexed) | Image: 30° Angulated Conical Multi-Unit (non-indexed) | Image: Titanium Base (CAD/CAM) | Image: Titanium Blank (CAD/CAM) | Image: FitPost (Hand Milled) | Image: Screws | |||
| 4.0, 4.5 | 3.6 | 2.89 | X | X | X | X | X | X | X |
| 4.5, 5.0, 5.5 | 4.2 | 2.89 | X | X | X | X | X | X | X |
| Material | Grade 5 - Titanium | ||||||||
| Finish | None | Blue Anodize | None | Yellow Anodize | None | None | None |
*3.0 mm Abutment screw – TiN-coated Phynox, not titanium
| ProstheticInterface(implant/abutment)Diameter(mm) | Subject Device Abutment Designs Compatible with Kontact Implants | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ImplantPlatformDiameterKontact(mm) | StraightNarrowConicalMulti-Unit | 30° Angulated NarrowConical and ConicalMulti-Unit | 30° AngulatedConicalMulti-Unit | Titanium Base(CAD/CAM) | TitaniumBlank(CAD/CAM) | FitPost(Hand Milled) | Screws* | |||
| Image: Straight Narrow Conical Multi-Unit (non-indexed) | Image: 30° Angulated Narrow Conical and Conical Multi-Unit (indexed) | Image: 30° Angulated Conical Multi-Unit (non-indexed) | Image: Titanium Base (CAD/CAM) | Image: Titanium Blank (CAD/CAM) | Image: FitPost (Hand Milled) | Image: Screws | ||||
| ImplantDiameterKontact(mm) | (non-indexed) | (indexed) | (non-indexed) | |||||||
| 3.0 | 3.0 | 2.49 | n/a | n/a | n/a | X | X | n/a | X | |
| 3.6 | 3.6 | 2.89 | X | X | X | X | X | X | X | |
| 4.2 | 4.2 | 2.89 | X | X | X | X | X | X | X | |
| 4.8 | 4.8 | 2.89 | X | X | X | X | X | X | X | |
| 5.4 | 5.4 | 2.89 | X | X | X | X | X | X | X | |
| Material | Grade 5 - Titanium | |||||||||
| Finish | None | Blue Anodize | None | Yellow Anodize | None | None | None |
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EQUIVALENCE TO MARKETED DEVICE
The Subject device is the same or highly similar in indications and design principles to the Primary Predicate device listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and tables comparing the technological characteristics of the Primary Predicate device and Reference devices.
The wording of the Indications for Use Statement (IFUS) of the Subject device is highly similar to that of the K210220 Primary Predicate device, differing only in the inclusion of the full device name, in reference to the 3 mm implants and the final paragraph which has been added to the IFUS to support fabrication of customized endosseous dental implant abutments by means of CAD/CAM technology. Similarly, the differences between the Subject device IFUS and that of each of the Reference devices are related to the specific device names and design features, validated milling centers, and the compatible implant lines. None of these minor differences impact substantial equivalence because all IFUS express equivalent intended use to facilitate dental prosthetic restorations, and the indications are expressed equivalently using different specific wording.
TECHNOLOGICAL CHARACTERISTICS
Subject device implants and abutments are the same or highly similar in intended use and designs to the sponsor's K210220 Primary Predicate device. The Subject device is to be sterilized by the end-user, using the same methods as previously validated for the sponsor's K210220 Primary Predicate device. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. Reference devices introduce additional abutment designs with the same or highly similar intended uses.
Implants
The Subject device Kontact S implants have the same implant diameter and lengths as the sponsor's Kontact K210220 Kontact implants but differ in material and modified surface treatment. The K122300 Reference device has similar implant and prosthetic diameters and similar implant lengths and is made from the same raw material as the Subject device Kontact S+ implants. Reference device K121787 is grit-blasted with the manufacturer's Resorbable Blast Texture (RBT) media (tricalcium phosphate) in a similar manner to the Subject device Kontact S implants supporting this technology in the Subject device. Additionally, the K121787 Reference device has similar implant dimensions. Slight differences between Subject device implants and Reference device implant dimensions and modified surfaces do not change the intended use of the devices and have been mitigated through nonclinical performance testing to demonstrate the Subject device is sufficient for intended use.
Abutments
The Subject and Primary Predicate device abutments are for single-unit or multi-unit restorations, have internal implant interface connections, and are made of Ti-6Al-4V ELI alloy (abutments and abutment screws). The Subject device abutment designs are highly similar to that of the K210220 Primary Predicate device designs: Straight Conical, Conical, Angulated Narrow Conical, Angulated Conical abutments. Titanium Blank and FitPost abutments are added by Reference devices.
Straight Narrow Conical Abutments
The K200817 Reference device is included for support of dental implant abutments which include a larger prosthetic diameter and the same and larger gingival height of the previously cleared Straight Narrow Conical abutments.
Angulated Narrow Conical and Angulated Conical Abutments
The Primary Predicate devices were limited to 17° angle correction. The K200817 Reference device in included in this submission to support the use of dental implant abutments which include a larger post correction angle and
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similar prosthetic diameter and gingival height. Angulated Narrow Conical and Angulated Conical Abutments and intended for multi-unit restorations.
Titanium Base Abutments
The Subject device Titanium base abutments are similar in design, materials, fabrication process and use as the K150203 Reference device. The Subject and K150203 Reference devices encompass a similar range of implant platforms. The Titanium Base Abutments consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment made of Zirconia conforming to ISO 13356) that composes the final abutment.
Titanium Blank Abutments
The Subject device Titanium base abutments are similar in design, materials, fabrication process and use as the K150203 Reference device. The Subject and K150203 Reference devices encompass a similar range of implant platform diameters, and both have a maximum post correction angle of 30 degrees for 3 mm implants).
FitPost Abutments
The Subject device FitPost abutments are similar in design, fabrication process and K210220 Primary Predicate device. They differ only in that they are provided with a pre-manufactured 30° post which can be customized for individual patient requirements. The K150203 Reference device is included to support the use of a modified abutment with a 30° post correction angle with similar implant platform diameters. While the methods of modification are different, both the Subject and Reference device are limited to 30° angulation. The compatible Kontact implant system is limited to 22° based on performance testing. The hand milling method of modification of an abutment is supported by the sponsor's K210220 Primary Predicate device.
Uni-Post Copings
Uni-Post Abutments were cleared as part of the K210220 Primary Predicate device and are cleared for use with Titanium sleeves which complete the two-part abutment upon the final prosthesis is cemented to. The Uni-Post copings in this submission perform the same function as the titanium sleeve but do so without the need to be hand modified for patient occlusion. The Uni-Post copings are similar to and supported by both the Uni-Post titanium sleeve and the titanium coping of the straight Conical Abutments of the K210220 Primary Predicate device. The Uni-Post copings share the same prosthetic diameters 4 mm, 5mm and 6.5 prosthetic diameters of the Primary Predicate device titanium sleeves and are similar to the 4.9 mm prosthetic diameter of the Conical Abutment copings.
Slight differences in dimensions between the Subject device copings and Primary Predicate device sleeves and copings are supported by the ISO 14801 performance testing of performed on worst-case constructs of the Subject device.
Minor differences in the designs, dimensions, or sizes between the Subject device, the Primary Predicate device, and the Reference devices do not affect substantial equivalence. Additional implant designs are supported by Reference devices. Overall, the Subject, Primary Predicate and Reference devices encompass a similar range of physical dimensions. Minor differences related to implant or abutment designs are mitigated by mechanical performance testing. ISO 14801 mechanical performance testing was performed on worstcase constructs of the Subject device to demonstrate suitability for intended use of the Subject device implant platform, gingival height, and post correction angles combinations.
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PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included: Biocompatibility evaluation and testing in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"; static compression and compression fatigue testing according to ISO 14801, Steam Sterilization according to ISO 17665-1 and ISO TS 17665-2, and an MRI Safety assessment.
The following confirmatory biological tests were performed:
| Biological Endpoint | Relevant Standard |
|---|---|
| Cytotoxicity | ISO 10993-5:2009 |
| Endotoxins | ANSI/AAMI ST72:2019 |
The biological evaluation included review of published literature, internal routine monitoring data related to implant modified surface treatment and post-market surveillance data on implants subject to the same modified surface treatment and cleaning process and made from the same material as the Subject device according to the following FDA guidance documents, Acceptance of Clinical Data to Support Medical Device Applications and Submissions and Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.
A published multi-center retrospective study evaluated implant failures and bone-level changes on male and female patients aged 19-90 years old implanted with the Subject device implants of varying diameters and lengths. Placement locations varied and included placement in extraction sockets, healed bone, and grafted bone locations. Bone levels of 326 were evaluated at time of abutment placement through a period of 50 months post implantation. Bone level decreases identified were less than 1 mm, well within accepted levels, with an overall implant survival rate of 98% at 1 year.
Review of historical SEM/EDS data was performed on implants made from the same material and surface treatment process as those covered in the published literature. Review of post market surveillance data and was performed to identify any significant trends in osseointegration failures. The results indicated failure rates below industry levels.
The endotoxin batch protocol and gamma sterilizations were leveraged from the prior K210220 Primary Predicate device clearance.
Non-clinical worst-case MRI review was performed to evaluate the Subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Any differences in implant or implant abutment designs or dimensions have been mitigated and demonstrated to be suitable for intended use through non-clinical bench performance testing.
The results of non-clinical performance testing demonstrate that the Subject device is suitable for intended use and is the same or highly similar to the Primary Predicate device.
CLINICAL TESTING
No animal or clinical testing was performed for this Premarket Notification.
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CONCLUSION
Overall, the Indications for Use statement for the Subject and Primary Predicate devices are the highly similar, differing slightly, only in device name. Overall, the Technological Characteristics of the Subject device are the same or highly similar to the Primary Predicate and Reference devices with any differences mitigated through non-clinical performance testing.
Overall, the data included in this premarket notification demonstrates substantial equivalence to the Primary Predicate device listed above.
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Indications for Use Comparison Table
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Kontact™ Dental ImplantSystem Biotech Dental,SAS | Kontact™ Dental ImplantSystem Biotech Dental, SASK210220 | 3i T3 Dental ImplantBIOMET 3iK122300 | Tapered Internal PlusImplants BioHorizonsImplant Systems, Inc.K121787 | Medentika CAD/CAM Abutments Medentika GmbHK150203 | URIS OMNI Narrow System &ProstheticTruAbutment Inc.K200817 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Kontact™ Dental ImplantSystem is indicated for usein partially or fullyedentulous patients tosupport maxillary ormandibular single unit,multiple-unit, oroverdenture dentalrestorations. Kontact™Dental Implant System isindicated for immediateloading when goodprimary stability isachieved and the occlusalloading is appropriate.Kontact™ Dental ImplantSystem 3 mm diameterimplants and prostheticscomponents are indicatedfor use in surgical andrestorative applications inthe maxillary lateral incisoror mandibular incisorregions.All digitally designedKontact™ Dental ImplantSystem CAD/CAMabutments are intended tobe sent to a Biotech Dentalvalidated milling center formanufacture. | Kontact™ Dental ImplantSystem is indicated for usein partially or fullyedentulous patients tosupport maxillary ormandibular single unit,multiple-unit, oroverdenture dentalrestorations. KontactDental Implant System isindicated for immediateloading when goodprimary stability isachieved and the occlusalloading is appropriate.Kontact 3 mm diameterimplants and prostheticscomponents are indicatedfor use in surgical andrestorative applications inthe maxillary lateral incisoror mandibularincisor regions. | BIOMET dental implantsare intended for surgicalplacement in the upper orlower jaw to provide ameans for prostheticattachment in single toothrestorations and inpartially or fullyedentulous spans withmultiple single teethutilizing delayed orimmediate loading, orwith a terminal orintermediary abutment forfixed or removablebridgework, and to retainoverdlentures. | BioHorizons TaperedInternal PlusImplants areintended for use inthe mandible ormaxilla as an artificialroot structure forsingle toothreplacement or forfixed bridgework anddental retention. Theimplants may berestored immediately(1) with a temporaryprosthesis that is notin functionalocclusion or (2) whensplinted together formultiple toothreplacement or whenstabilized with anoverdenturesupported bymultiple implants. | Medentika TiBase CAD/CAM Abutments are intendedfor use with dental implants as a support for single ormultiple tooth prostheses in the maxilla or mandible ofa partially or fully edentulous patient.Implant SystemCompatibility Series ImplantDiameter (mm) PlatformDiameter (mm) Nobel BiocareReplace™ Select E 3.5, 4.3, 5.0, 6.0 3.5, 4.3, 5.0,6.0 Nobel BiocareNobelActive™ F 3.5, 4.3, 5.0 3.5, 3.9 (4.3),3.9 (5.0) Biomet 3iOsseotite®Certain® H 3.25, 4.0, 5.0 3.4, 4.1, 5.0 Biomet 3iOsseotite® I 3.25, 3.75, 4.0,5.0 3.4, 4.1, 5.0 Nobel BiocareBrånemark K 3.3, 3.75, 4.0,5.0 3.5, 4.1, 4.1,5.1 Straumann BoneLevel L 3.3, 4.1, 4.8 3.3, 4.1, 4.8 StraumannStandard N 3.3, 4.1, 4.8 3.5(NNC), 4.8,6.5 Zimmer TaperedScrew-vent® R 3.3, 3.7, 4.1,4.7, 6.0 3.5, 4.5, 5.7 Astra TechOsseoSpeed™ S 3.5, 4.0, 4.5, 5.0 3.5, 4.0, 4.5,5.0 DentsplyFriadent®Frialit/XiVE® T 3.4, 3.8, 4.5, 5.5 3.4, 3.8, 4.5,5.5 DentsplyFriadent®Ankylos® Y 3.5, 4.5, 5.5, 7.0 3.5, 4.5, 5.5,7.0Medentika TiBase is intended for use with theStraumann® CARES® System. All digitally designedabutments for use with Medentika CAD/CAMAbutments are intended to be manufactured at aStraumann® CARES® validated milling center. | Medentika Preface CAD/CAM Abutments are intendedfor use with dental implants as a support for single ormultiple tooth prostheses in the maxilla or mandible ofa partially or fully edentulous patient.Implant SystemCompatibility Series ImplantDiameter (mm) PlatformDiameter (mm) Nobel BiocareReplace™ Select E 3.5, 4.3, 5.0, 6.0 3.5, 4.3, 5.0,6.0 Nobel BiocareNobelActive™ F 3.0, 3.5, 4.3, 5.0 3.0, 3.5, 3.9(4.3), 3.9 (5.0) Biomet 3iOsseotite®Certain® H 3.25, 4.0, 5.0 3.4, 4.1, 5.0 Biomet 3iOsseotite® I 3.25, 3.75, 4.0,5.0 3.4, 4.1, 5.0 Nobel BiocareBrånemark K 3.3, 3.75, 4.0,5.0 3.5, 4.1, 4.1,5.1 Straumann BoneLevel L 3.3, 4.1, 4.8 3.3, 4.1, 4.8 StraumannStandard N 3.3, 4.1, 4.8 3.5(NNC), 4.8,6.5 Zimmer TaperedScrew-vent® R 3.3, 3.7, 4.1,4.7, 6.0 3.5, 4.5, 5.7 Astra TechOsseoSpeed™ S 3.0, 3.5, 4.0,4.5, 5.0 3.0, 3.5, 4.0,4.5, 5.0 DentsplyFriadent®Frialit/XiVE® T 3.4, 3.8, 4.5, 5.5 3.4, 3.8, 4.5,5.5Medentika PreFace is intended for use with theStraumann® CARES® System. All digitally designedabutments for use with Medentika CAD/CAMAbutments are intended to be manufactured at aStraumann® CARES® validated milling center. | URIS OMNI Narrow System isindicated for use in thetreatment of missing maxillarylateral incisors or themandibular central and lateralincisors, in support of single ormultiple-unit restorationsincluding: cemented retained,screw retained, or overdenturerestorations, and final ortemporary abutment supportfor fixed bridgework. It isintended for delayed loading.The URIS OMNI Prostheticabutments are intended foruse with URIS OMNI dentalimplants to provide support forprosthetic restorations such ascrowns, bridges, or over-dentures.All digitally designedabutments and/or coping foruse with URIS OMNI Prostheticabutments are intended to besent to a TruAbutment-validated milling center formanufacture. |
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Technological Characteristics Comparison Table – Implants
| Comparison | Subject DeviceKontact™ Dental Implant SystemBiotech Dental, SAS | Primary Predicate DeviceKontact™ Dental Implant SystemBiotech Dental, SAS (K210220) | Reference Device3i T3 Dental ImplantBIOMET 3i (K122300) | Reference DeviceTapered Internal Plus ImplantsBioHorizons Implant Systems, Inc. (K121787) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Product Code | DZE, NHA | DZE, NHA | DZE | DZE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Regulation | 872.3640, 872.3630 | 872.3640, 872.3630 | 872.3640 | 872.3640 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Intended Use | Functional and esthetic rehabilitation ofthe edentulous maxilla and mandible | Functional and esthetic rehabilitation of theedentulous maxilla and mandible | Functional and esthetic rehabilitation of theedentulous maxilla and mandible | Functional and esthetic rehabilitation of the edentulousmaxilla and mandible | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Reason forPredicate/Reference | Not Applicable | Implant diameter/length, prosthetic connection,sterilization, biocompatibility and how provided | Implant diameter/length, Implant material | β-TCP grit blast surface | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Prosthetic InterfaceConnection | Internal | Implant DesignsInternal | Internal | Internal | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| D = Implant Body DiameterIP = Implant PlatformDiameter | Kontact SD IP Lengths 3.0 3.0 10, 12, 14 3.6 3.6 8,10,12,14,16 4.2 4.2 8,10,12,14,16 4.8 4.8 8,10,12,14 5.4 5.4 8,10,12,14 Tapered Implant body, spherical apexCP Grade 4 Titaniumβ-TCP grit blast surfaceKontact S+D IP Lengths 4.0 3.6 8, 10, 12 4.5 3.6 8, 10, 12 4.5 4.2 8, 10, 12 5.0 4.2 8, 10, 12 5.5 4.2 8, 10, 12 Tapered Implant body, spherical apexCP Grade 4 Titaniumβ-TCP grit blast surface | KontactD IP Lengths 3.0 3.0 10, 12, 14 3.6 3.6 8,10,12,14,16 4.2 4.2 8,10,12,14,16 4.8 4.8 8,10,12,14 5.4 5.4 8,10,12,14 Tapered Implant body, spherical apexGrade 5 Titanium AlloyAL2O3 grit blast surface | T3 Tapered ImplantsD IP Lengths 4.0 3.4 8.5,10,11.5,13,15 5.0 4.1 8.5,10,11.5,13,15 6.0 5.0 8.5,10,11.5,13,15 Tapered Implant body, spherical apexCP Grade 4 TitaniumDiscrete crystalline deposition (DCD), CalciumPhosphate (CaP) surface | D IP Lengths 3.8 3.0 9,10.5,12,15 4.6 3.5 7.5,9,10.5,12,15 5.8 4.5 7.5,9,10.5,12,15 Tapered Implant body, spherical apexGrade 5 Titanium Alloyβ-TCP grit blast surface |
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| Comparison | Subject DeviceKontact™ Dental Implant SystemBiotech Dental, SAS | Primary Predicate DeviceKontact™ Dental Implant SystemBiotech Dental, SASK210220 | Reference DeviceMedentika CAD/CAM AbutmentsMedentika GmbHK150203 | Reference DeviceURIS OMNI Narrow System & ProstheticTruAbutment Inc.K200817 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Product Code | DZE, NHA | DZE, NHA | NHA | NHA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Regulation | 872.3640, 872.3630 | 872.3640, 872.3630 | 872.3630 | 872.3630 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Intended Use | Functional and esthetic rehabilitation of the edentulous maxilla and mandible | Functional and esthetic rehabilitation of the edentulous maxilla and mandible | Functional and esthetic rehabilitation of the edentulous maxilla and mandible | Functional and esthetic rehabilitation of the edentulous maxilla and mandible | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Reason forPredicate/Reference | Not Applicable | Abutment designs listed, material, sterilization, biocompatibility, how provided | CAD/CAM Ti-Base and Ti-Blank Abutment Design, Modified abutment maximum post correction angle | Straight MUA PD/GH, Angled Abutment increased post correction angle | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abutment Design | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Straight Narrow Conical (non-indexed) | Narrow Conical AbutmentsImplant Platform Diameter:3.6, 4.2, 4.8, 5.4 mmProsthetic Platform Ø: 4.0 mmAngle: 0°, Gingival Height: 1-4 mmAngle: 17°, Gingival Height: 4 mmIndexed, non-indexedTitanium Alloy (ASTM F136) | n/a | Multi-Unit Straight AbutmentsPD: 5.0mmGH: 1.0/2.0/3.0/4.0/5.0/6.0 mmPH: not defined | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| D IP GH PD Max CA PH Min APH 3.6 3.6 5 4 0 1.2 3.2 4.2 4.2 5 4 0 1.2 3.2 4.8 4.8 5 4 0 1.2 3.2 5.4 5.4 5 4 0 1.2 3.2 4.0 3.6 5 4 0 1.2 3.2 4.5 3.6 5 4 0 1.2 3.2 4.5 4.2 5 4 0 1.2 3.2 5.0 4.2 5 4 0 1.2 3.2 5.5 4.2 5 4 0 1.2 3.2 Min PH with Conical coping 3.2 mm Min PH with Titanium Sleeve 4 mm Titanium Alloy (ASTM F136), no modified surface Copings - anodized yellow | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| D = Implant Body DiameterIP = Implant Platform DiameterGH = Gingival HeightPD = Prosthetic Diameter(Gingival Diameter)CA = Post Correction AnglePH = Post HeightAPH = Accessory Post Height(Multi-Unit Abutments) | 30° Angulated Narrow Conical (indexed) | n/a | Multi-Unit Angled AbutmentsPD: 5.0mmGH: 4.0/5.0/6.0mmCA: 29.5PH: not defined | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| D IP GH PD Max CA PH Min APH 3.6 3.6 4 4 30 2.1 3.2 4.2 4.2 4 4 30 2.1 3.2 4.8 4.8 4 4 30 2.1 3.2 5.4 5.4 4 4 30 2.1 3.2 4.0 3.6 4 4 30 2.1 3.2 4.5 3.6 4 4 30 2.1 3.2 4.5 4.2 4 4 30 2.1 3.2 5.0 4.2 4 4 30 2.1 3.2 5.5 4.2 4 4 30 2.1 3.2 Min PH with Conical coping 3.2 mm Min PH with Titanium Sleeve 4 mm Titanium Alloy (ASTM F136), post insert - Anodized Blue Copings - anodized yellow | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 30° Angulated Conical (indexed, non-indexed) | Angulated Conical AbutmentsImplant Platform Diameter:3.6, 4.2, 4.8, 5.4 mmProsthetic Platform Ø: 4.9 mmAngle: 17°, Gingival Height: 2-5 mmIndexed, non-indexedTitanium Alloy (ASTM F136) | n/a | Multi-Unit Straight AbutmentsPD: 5.0mmGH: 4.0/5.0/6.0mmCA: 29.5PH: not defined | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| D IP GH PD Max CA PH Min APH 3.6 3.6 2,3,4,5 4.9 30 2.3 4.0 4.2 4.2 2,3,4,5 4.9 30 2.3 4.0 4.8 4.8 2,3,4,5 4.9 30 2.3 4.0 5.4 5.4 2,3,4,5 4.9 30 2.3 4.0 4.0 3.6 2,3,4,5 4.9 30 2.3 4.0 4.5 3.6 2,3,4,5 4.9 30 2.3 4.0 4.5 4.2 2,3,4,5 4.9 30 2.3 4.0 5.0 4.2 2,3,4,5 4.9 30 2.3 4.0 5.5 4.2 2,3,4,5 4.9 30 2.3 4.0 Min PH with Conical coping 4.7 mm Min PH with Titanium Sleeve 4 mm Titanium Alloy (ASTM F136), no modified surface Copings - anodized yellow |
Technological Characteristics Comparison Table - Abutments
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| Comparison | Subject Device | Primary Predicate Device | Reference Device | Reference Device | |||||
|---|---|---|---|---|---|---|---|---|---|
| Kontact™ Dental Implant System | Kontact™ Dental Implant System | Medentika CAD/CAM Abutments | URIS OMNI Narrow System & Prosthetic | ||||||
| Biotech Dental, SAS | Biotech Dental, SAS | Medentika GmbH | TruAbutment Inc. | ||||||
| K210220 | K150203 | K200817 | |||||||
| Titanium Base | Titanium Base:Implant Platform Ø: 3.0-7.0 mm | ||||||||
| IP | GH | Max PD | Max CA | PH | Gingival Height: not specified | ||||
| 3.0 | 1.5, 3, 4, 5 | 5 | 3.9-6.4 | 0 | 4 | ||||
| 3.6 | 4.0 | ||||||||
| 4.2 | 0.7, 1, 2, 3, 4, 5 | 5 | 3.9-6.4 | 0 | n/a | n/a | |||
| 4.8 | 5.5 | ||||||||
| 5.4 | |||||||||
| Indexed, Titanium Alloy (ASTM F136)Zirconia mesostructure conforming to ISO 13356Anodized Yellow | |||||||||
| Titanium Blank | Titanium Blanks: | ||||||||
| IP | Max GH | Max CA | Min PH | Implant Platform Ø: 3.0-7.0 mm | |||||
| 3.0 | 5 | 15 | 4 | Gingival Height: not specifiedAngle: 0 - 30° | |||||
| 3.6 | 5 | 30* | 4 | Min PH: not specified | |||||
| 4.2 | 5 | 30* | 4 | Indexed | n/a | n/a | |||
| 4.8 | 5 | 30* | 4 | Titanium Alloy | |||||
| 5.4 | 5 | 30* | 4 | ||||||
| IndexedTitanium Alloy (ASTM F136), no modified surface*Max 22° with Kontact Implants | |||||||||
| FitPost (Hand Milled) | FitPost | Titanium Blanks: | |||||||
| IP | GH | PD | Max CA | Min PH | Implant Platform Ø: 3.6, 4.2, 4.8, 5.4 mmProsthetic Diameter: 5.1, 6.6 mm | Implant Platform Ø: 3.0-7.0 mmGingival Height: not specified | |||
| 3.6, 4.2, 4.8, 5.4 | 1, 2, 3, 4, 5 | 5 | 30* | 4 | Gingival Height: 1-5 mmAngle: 0°Min PH: 4 mm | Angle: 0 - 30°Min PH: not specifiedIndexed | n/a | ||
| IndexedTitanium Alloy (ASTM F136), no modified surface*Max 22° with Kontact Implants | IndexedTitanium Alloy (ASTM F136), no modified surface | Titanium Alloy | |||||||
| Uni-Post Copings (for use with Uni-Post abutments)(table reflects Uni-Post abutment with Insert) | Uni-Post Abutments w/Sleeves | ||||||||
| IP | GH | PD | Max CA | PH APH | Implant Platform Ø: 3.6, 4.2, 4.8, 5.4 mmProsthetic Diameter: 4, 5, 6.5 mmGingival Height: 1 mm – 5 mm | ||||
| 3.6, 4.2, 4.8, 5.4 | 1, 2, 3, 4, 5 | 4, 5 | 0 | 2.1 | 4.9 | Straight Conical Abutment w/copingProsthetic Platform Ø: 4.0 mm, 4.9 mmGingival Height: 1-5 mm | n/a | n/a | |
| 3.6, 4.2, 4.8, 5.4 | 2, 3, 4, 5 | 6.5 | 0 | 2.1 | 4.9 | Angle: 0°Indexed, Non-IndexedGrade 5 Titanium Alloy | |||
| PH with Uni-Post Insert 4.9 mmTitanium Alloy (ASTM F136), anodized yellow | |||||||||
| Material | Ti-6AL-4V Alloy | Ti-6AL-4V Alloy | Ti-6AL-4V Alloy | Ti-6AL-4V Alloy | |||||
| (Abutment and Screw)Abutment/Implant Interface | 3.0 mm Abutment screw - PhynoxInternal Connection | 3.0 mm Abutment screw - PhynoxInternal Connection | Internal Connection | Internal Connection | |||||
| Prosthesis Attachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retained | Multi-unit | |||||
| Restoration | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Multi-unit | |||||
| How Provided | |||||||||
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | |||||
| Sterilization Method | Moist Heat | Moist Heat | Moist Heat | Moist Heat | |||||
| Usage | Single patient, single use | Single patient, single use | Single patient, single use | Single patient, single use |
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.