Kontact Dental Implant System

K213997 · Biotech Dental, Sas · DZE · Jul 15, 2022 · Dental

Device Facts

• Record ID: K213997
• Device Name: Kontact Dental Implant System
• Applicant: Biotech Dental, Sas
• Product Code: DZE · Dental
• Decision Date: Jul 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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.

Device Story

Endosseous root-form dental implants and prosthetic components; used for single-unit, multi-unit, and overdenture restorations. Implants (Kontact S and S+) manufactured from Grade 4 titanium (ASTM F67/ISO 5832-2); S+ implants feature grit-blasted surface with resorbable beta-tricalcium phosphate (β-TCP) to facilitate osseointegration. Prosthetic components (abutments, screws) manufactured from Grade 5 titanium alloy (ASTM F136/ISO 5832-3). System includes straight/angulated conical abutments, titanium bases, titanium blanks, and hand-milled FitPost abutments. Used in dental clinics by clinicians; CAD/CAM abutments require fabrication at validated milling centers. Output is a stable foundation for dental prostheses; benefits include functional and esthetic rehabilitation of edentulous patients.

Clinical Evidence

No clinical or animal testing performed. Evidence includes biocompatibility testing (ISO 10993-5, ANSI/AAMI ST72), static/fatigue compression testing (ISO 14801), and MRI safety assessment. Retrospective literature review of 326 implants showed 98% survival rate at 1 year with <1 mm bone loss.

Technological Characteristics

Materials: Grade 4 titanium (ASTM F67) for implants; Grade 5 titanium alloy (ASTM F136) for abutments. Surface: Grit-blasted with β-TCP. Connection: Internal. Sterilization: Moist heat (end-user). CAD/CAM workflow: Validated milling centers. Mechanical testing: ISO 14801.

Indications for Use

Indicated for partially or fully edentulous patients requiring maxillary or mandibular single-unit, multiple-unit, or overdenture dental restorations. Supports immediate loading if primary stability is achieved and occlusal loading is appropriate. 3 mm diameter implants/components indicated for maxillary lateral incisor or mandibular incisor regions.

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

• Kontact™ Dental Implant System (K210220)

Reference Devices

• 3i T3 Dental Implant (K122300)
• Medentika CAD/CAM Abutments (K150203)
• URIS OMNI Narrow System & Prosthetic (K200817)
• Tapered Internal Plus Implants (K121787)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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*)

| <span>☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------|
| <span>☐</span> 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, SAS<br>305, Allées de Craponne<br>13300 Salon de Provence |
|---------------------------------------|-----------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| Official Contact: | Delphine Mercier, VP Compliance |
| Email: | [e-mail] |
| <b>DEVICE NAME AND CLASSIFICATION</b> | |
| 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)<br>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

K150203

K200817

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.

| Implant<br>Type | Implant Body<br>Diameter (mm) | Implant Platform<br>Diameter (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 | | | | | | | |
|----------|------------------------------------------|------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------|----------------------------------------|----------------------------|--------------------------------|--------------------------|---------|
| | Implant<br>Diameter<br>Kontact S<br>(mm) | Implant<br>Platform<br>Diameter<br>Kontact S<br>(mm) | Prosthetic<br>Interface<br>(implant/<br>abutment)<br>Diameter<br>(mm) | Straight<br>Narrow<br>Conical<br>Multi-Unit | 30° Angulated Narrow<br>Conical and Conical<br>Multi-Unit | 30° Angulated<br>Conical<br>Multi-Unit | Titanium Base<br>(CAD/CAM) | Titanium<br>Blank<br>(CAD/CAM) | FitPost<br>(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

| Implant<br>Diameter<br>Kontact S+<br>(mm) | Implant<br>Platform<br>Diameter<br>Kontact S+<br>(mm) | Prosthetic<br>Interface<br>(implant/<br>abutment)<br>Diameter<br>(mm) | Straight<br>Narrow<br>Conical<br>Multi-Unit | 30° Angulated Narrow<br>Conical and Conical<br>Multi-Unit | 30° Angulated<br>Conical<br>Multi-Unit | Titanium Base<br>(CAD/CAM) | Titanium<br>Blank<br>(CAD/CAM) | FitPost<br>(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

| | | Prosthetic<br>Interface<br>(implant/<br>abutment)<br>Diameter<br>(mm) | Subject Device Abutment Designs Compatible with Kontact Implants | | | | | | | |
|----------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------|--------------------------------|---------------------------------|------------------------------|---------------|--|
| | Implant<br>Platform<br>Diameter<br>Kontact<br>(mm) | | Straight<br>Narrow<br>Conical<br>Multi-Unit | 30° Angulated Narrow<br>Conical and Conical<br>Multi-Unit | 30° Angulated<br>Conical<br>Multi-Unit | Titanium Base<br>(CAD/CAM) | Titanium<br>Blank<br>(CAD/CAM) | FitPost<br>(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 | |
| Implant<br>Diameter<br>Kontact<br>(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 Implant<br>System Biotech Dental,<br>SAS | Kontact™ Dental Implant<br>System Biotech Dental, SAS<br>K210220 | 3i T3 Dental Implant<br>BIOMET 3i<br>K122300 | Tapered Internal Plus<br>Implants BioHorizons<br>Implant Systems, Inc.<br>K121787 | Medentika CAD/CAM Abutments Medentika GmbH<br>K150203 | URIS OMNI Narrow System &<br>Prosthetic<br>TruAbutment Inc.<br>K200817 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Kontact™ Dental Implant<br>System is indicated for use<br>in partially or fully<br>edentulous patients to<br>support maxillary or<br>mandibular single unit,<br>multiple-unit, or<br>overdenture dental<br>restorations. Kontact™<br>Dental Implant System is<br>indicated for immediate<br>loading when good<br>primary stability is<br>achieved and the occlusal<br>loading is appropriate.<br>Kontact™ Dental Implant<br>System 3 mm diameter<br>implants and prosthetics<br>components are indicated<br>for use in surgical and<br>restorative applications in<br>the maxillary lateral incisor<br>or mandibular incisor<br>regions.<br><br>All digitally designed<br>Kontact™ Dental Implant<br>System CAD/CAM<br>abutments are intended to<br>be sent to a Biotech Dental<br>validated milling center for<br>manufacture. | Kontact™ Dental Implant<br>System is indicated for use<br>in partially or fully<br>edentulous patients to<br>support maxillary or<br>mandibular single unit,<br>multiple-unit, or<br>overdenture dental<br>restorations. Kontact<br>Dental Implant System is<br>indicated for immediate<br>loading when good<br>primary stability is<br>achieved and the occlusal<br>loading is appropriate.<br>Kontact 3 mm diameter<br>implants and prosthetics<br>components are indicated<br>for use in surgical and<br>restorative applications in<br>the maxillary lateral incisor<br>or mandibular<br>incisor regions. | BIOMET dental implants<br>are intended for surgical<br>placement in the upper or<br>lower jaw to provide a<br>means for prosthetic<br>attachment in single tooth<br>restorations and in<br>partially or fully<br>edentulous spans with<br>multiple single teeth<br>utilizing delayed or<br>immediate loading, or<br>with a terminal or<br>intermediary abutment for<br>fixed or removable<br>bridgework, and to retain<br>overdlentures. | BioHorizons Tapered<br>Internal Plus<br>Implants are<br>intended for use in<br>the mandible or<br>maxilla as an artificial<br>root structure for<br>single tooth<br>replacement or for<br>fixed bridgework and<br>dental retention. The<br>implants may be<br>restored immediately<br>(1) with a temporary<br>prosthesis that is not<br>in functional<br>occlusion or (2) when<br>splinted together for<br>multiple tooth<br>replacement or when<br>stabilized with an<br>overdenture<br>supported by<br>multiple implants. | Medentika TiBase CAD/CAM Abutments are intended<br>for use with dental implants as a support for single or<br>multiple tooth prostheses in the maxilla or mandible of<br>a partially or fully edentulous patient.<br><br>Implant System<br>Compatibility Series Implant<br>Diameter (mm) Platform<br>Diameter (mm) Nobel Biocare<br>Replace™ Select E 3.5, 4.3, 5.0, 6.0 3.5, 4.3, 5.0,<br>6.0 Nobel Biocare<br>NobelActive™ F 3.5, 4.3, 5.0 3.5, 3.9 (4.3),<br>3.9 (5.0) Biomet 3i<br>Osseotite®<br>Certain® H 3.25, 4.0, 5.0 3.4, 4.1, 5.0 Biomet 3i<br>Osseotite® I 3.25, 3.75, 4.0,<br>5.0 3.4, 4.1, 5.0 Nobel Biocare<br>Brånemark K 3.3, 3.75, 4.0,<br>5.0 3.5, 4.1, 4.1,<br>5.1 Straumann Bone<br>Level L 3.3, 4.1, 4.8 3.3, 4.1, 4.8 Straumann<br>Standard N 3.3, 4.1, 4.8 3.5(NNC), 4.8,<br>6.5 Zimmer Tapered<br>Screw-vent® R 3.3, 3.7, 4.1,<br>4.7, 6.0 3.5, 4.5, 5.7 Astra Tech<br>OsseoSpeed™ S 3.5, 4.0, 4.5, 5.0 3.5, 4.0, 4.5,<br>5.0 Dentsply<br>Friadent®<br>Frialit/XiVE® T 3.4, 3.8, 4.5, 5.5 3.4, 3.8, 4.5,<br>5.5 Dentsply<br>Friadent®<br>Ankylos® Y 3.5, 4.5, 5.5, 7.0 3.5, 4.5, 5.5,<br>7.0<br>Medentika TiBase is intended for use with the<br>Straumann® CARES® System. All digitally designed<br>abutments for use with Medentika CAD/CAM<br>Abutments are intended to be manufactured at a<br>Straumann® CARES® validated milling center. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Medentika Preface CAD/CAM Abutments are intended<br>for use with dental implants as a support for single or<br>multiple tooth prostheses in the maxilla or mandible of<br>a partially or fully edentulous patient.<br><br>Implant System<br>Compatibility Series Implant<br>Diameter (mm) Platform<br>Diameter (mm) Nobel Biocare<br>Replace™ Select E 3.5, 4.3, 5.0, 6.0 3.5, 4.3, 5.0,<br>6.0 Nobel Biocare<br>NobelActive™ F 3.0, 3.5, 4.3, 5.0 3.0, 3.5, 3.9<br>(4.3), 3.9 (5.0) Biomet 3i<br>Osseotite®<br>Certain® H 3.25, 4.0, 5.0 3.4, 4.1, 5.0 Biomet 3i<br>Osseotite® I 3.25, 3.75, 4.0,<br>5.0 3.4, 4.1, 5.0 Nobel Biocare<br>Brånemark K 3.3, 3.75, 4.0,<br>5.0 3.5, 4.1, 4.1,<br>5.1 Straumann Bone<br>Level L 3.3, 4.1, 4.8 3.3, 4.1, 4.8 Straumann<br>Standard N 3.3, 4.1, 4.8 3.5(NNC), 4.8,<br>6.5 Zimmer Tapered<br>Screw-vent® R 3.3, 3.7, 4.1,<br>4.7, 6.0 3.5, 4.5, 5.7 Astra Tech<br>OsseoSpeed™ S 3.0, 3.5, 4.0,<br>4.5, 5.0 3.0, 3.5, 4.0,<br>4.5, 5.0 Dentsply<br>Friadent®<br>Frialit/XiVE® T 3.4, 3.8, 4.5, 5.5 3.4, 3.8, 4.5,<br>5.5<br>Medentika PreFace is intended for use with the<br>Straumann® CARES® System. All digitally designed<br>abutments for use with Medentika CAD/CAM<br>Abutments are intended to be manufactured at a<br>Straumann® CARES® validated milling center. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | URIS OMNI Narrow System is<br>indicated for use in the<br>treatment of missing maxillary<br>lateral incisors or the<br>mandibular central and lateral<br>incisors, in support of single or<br>multiple-unit restorations<br>including: cemented retained,<br>screw retained, or overdenture<br>restorations, and final or<br>temporary abutment support<br>for fixed bridgework. It is<br>intended for delayed loading.<br><br>The URIS OMNI Prosthetic<br>abutments are intended for<br>use with URIS OMNI dental<br>implants to provide support for<br>prosthetic restorations such as<br>crowns, bridges, or over-<br>dentures.<br><br>All digitally designed<br>abutments and/or coping for<br>use with URIS OMNI Prosthetic<br>abutments are intended to be<br>sent to a TruAbutment-<br>validated milling center for<br>manufacture. |

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### Technological Characteristics Comparison Table – Implants

| Comparison | Subject Device<br>Kontact™ Dental Implant System<br>Biotech Dental, SAS | Primary Predicate Device<br>Kontact™ Dental Implant System<br>Biotech Dental, SAS (K210220) | Reference Device<br>3i T3 Dental Implant<br>BIOMET 3i (K122300) | Reference Device<br>Tapered Internal Plus Implants<br>BioHorizons 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 of<br>the edentulous maxilla and mandible | Functional and esthetic rehabilitation of the<br>edentulous maxilla and mandible | Functional and esthetic rehabilitation of the<br>edentulous maxilla and mandible | Functional and esthetic rehabilitation of the edentulous<br>maxilla and mandible | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reason for<br>Predicate/Reference | Not Applicable | Implant diameter/length, prosthetic connection,<br>sterilization, biocompatibility and how provided | Implant diameter/length, Implant material | β-TCP grit blast surface | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Prosthetic Interface<br>Connection | Internal | Implant Designs<br>Internal | Internal | Internal | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| D = Implant Body Diameter<br>IP = Implant Platform<br>Diameter | Kontact S<br>D 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 apex<br>CP Grade 4 Titanium<br>β-TCP grit blast surface<br>Kontact S+<br>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 apex<br>CP Grade 4 Titanium<br>β-TCP grit blast surface | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Kontact<br>D 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 apex<br>Grade 5 Titanium Alloy<br>AL2O3 grit blast surface | | | | | | | | | | | | | | | | | | | T3 Tapered Implants<br>D 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 apex<br>CP Grade 4 Titanium<br>Discrete crystalline deposition (DCD), Calcium<br>Phosphate (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 apex<br>Grade 5 Titanium Alloy<br>β-TCP grit blast surface | | | | | | | | | | | | |

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| Comparison | Subject Device<br>Kontact™ Dental Implant System<br>Biotech Dental, SAS | Primary Predicate Device<br>Kontact™ Dental Implant System<br>Biotech Dental, SAS<br>K210220 | Reference Device<br>Medentika CAD/CAM Abutments<br>Medentika GmbH<br>K150203 | Reference Device<br>URIS OMNI Narrow System & Pro…