Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant system and its components, focusing on materials, dimensions, mechanical testing, and biological evaluation. There is no mention of AI or ML in the intended use, device description, performance studies, or any other section.

Therapeutic

Yes

This device is a dental implant system used to support dental restorations, which is a therapeutic intervention for edentulous patients.

Diagnostic

No

The device is a dental implant system used for supporting dental restorations in edentulous patients. It is a therapy device, not one that diagnoses a condition.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components such as endosseous root-form dental implants, prosthetic components, abutments, and screws, all made from materials like titanium. While it mentions digitally designed CAD/CAM abutments, these are sent to a milling center for physical manufacture, indicating a hardware component. The performance studies also focus on physical properties and biological interactions of these hardware components.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for supporting dental restorations in patients. This is a direct clinical application within the body, not a test performed on samples outside the body to diagnose a condition.
Device Description: The description details physical components like implants, abutments, and screws, all designed for surgical implantation and prosthetic attachment. This aligns with a medical device used for treatment or restoration, not a diagnostic test.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing information for diagnosis, monitoring, or screening of diseases or conditions

The device is a dental implant system, which is a type of medical device used for surgical and restorative purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary or mandibular (jaw for implants), maxillary lateral incisor or mandibular incisor regions (for 3mm implants and prosthetics components)

Indicated Patient Age Range

19-90 years old

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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: Cytotoxicity (ISO 10993-5:2009), Endotoxins (ANSI/AAMI ST72:2019). 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 were reviewed.

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 was performed to identify any significant trends in osseointegration failures. The results indicated failure rates below industry levels.

Non-clinical worst-case MRI review was performed to evaluate the Subject device components in the MRI environment using scientific rationale and published literature, based on the entire system including all variations (all compatible implant bodies, abutments, and fixation screws) and material composition.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Bone level decreases identified were less than 1 mm.
overall implant survival rate of 98% at 1 year.
failure rates below industry levels.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K210220

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K122300, K150203, K200817

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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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, SAS
305, Allées de Craponne
13300 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

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.

4

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

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

| | | Prosthetic
Interface
(implant/
abutment)
Diameter
(mm) | Subject Device Abutment Designs Compatible with Kontact Implants | | | | | | | |
|----------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------|--------------------------------|---------------------------------|------------------------------|---------------|--|
| | Implant
Platform
Diameter
Kontact
(mm) | | Straight
Narrow
Conical
Multi-Unit | 30° Angulated Narrow
Conical and Conical
Multi-Unit | 30° Angulated
Conical
Multi-Unit | Titanium Base
(CAD/CAM) | Titanium
Blank
(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 | |
| Implant
Diameter
Kontact
(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.

8

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.

9

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.

10

Indications for Use Comparison Table

Subject Device	Primary Predicate Device	Reference Device	Reference Device	Reference Device	Reference Device
Kontact™ Dental Implant
System Biotech Dental,
SAS	Kontact™ Dental Implant
System Biotech Dental, SAS
K210220	3i T3 Dental Implant
BIOMET 3i
K122300	Tapered Internal Plus
Implants BioHorizons
Implant Systems, Inc.
K121787	Medentika CAD/CAM Abutments Medentika GmbH
K150203	URIS OMNI Narrow System &
Prosthetic
TruAbutment Inc.
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.

All digitally designed
Kontact™ Dental Implant
System CAD/CAM
abutments are intended to
be sent to a Biotech Dental
validated milling center for
manufacture. | 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 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. | BIOMET dental implants
are intended for surgical
placement in the upper or
lower jaw to provide a
means for prosthetic
attachment in single tooth
restorations and in
partially or fully
edentulous spans with
multiple single teeth
utilizing delayed or
immediate loading, or
with a terminal or
intermediary abutment for
fixed or removable
bridgework, and to retain
overdlentures. | BioHorizons Tapered
Internal Plus
Implants are
intended for use in
the mandible or
maxilla as an artificial
root structure for
single tooth
replacement or for
fixed bridgework and
dental retention. The
implants may be
restored immediately
(1) with a temporary
prosthesis that is not
in functional
occlusion or (2) when
splinted together for
multiple tooth
replacement or when
stabilized with an
overdenture
supported by
multiple implants. | Medentika TiBase CAD/CAM Abutments are intended
for use with dental implants as a support for single or
multiple tooth prostheses in the maxilla or mandible of
a partially or fully edentulous patient.

Implant System
Compatibility Series Implant
Diameter (mm) Platform
Diameter (mm) Nobel Biocare
Replace™ Select E 3.5, 4.3, 5.0, 6.0 3.5, 4.3, 5.0,
6.0 Nobel Biocare
NobelActive™ F 3.5, 4.3, 5.0 3.5, 3.9 (4.3),
3.9 (5.0) Biomet 3i
Osseotite®
Certain® H 3.25, 4.0, 5.0 3.4, 4.1, 5.0 Biomet 3i
Osseotite® I 3.25, 3.75, 4.0,
5.0 3.4, 4.1, 5.0 Nobel Biocare
Brånemark K 3.3, 3.75, 4.0,
5.0 3.5, 4.1, 4.1,
5.1 Straumann Bone
Level L 3.3, 4.1, 4.8 3.3, 4.1, 4.8 Straumann
Standard N 3.3, 4.1, 4.8 3.5(NNC), 4.8,
6.5 Zimmer Tapered
Screw-vent® R 3.3, 3.7, 4.1,
4.7, 6.0 3.5, 4.5, 5.7 Astra Tech
OsseoSpeed™ S 3.5, 4.0, 4.5, 5.0 3.5, 4.0, 4.5,
5.0 Dentsply
Friadent®
Frialit/XiVE® T 3.4, 3.8, 4.5, 5.5 3.4, 3.8, 4.5,
5.5 Dentsply
Friadent®
Ankylos® Y 3.5, 4.5, 5.5, 7.0 3.5, 4.5, 5.5,
7.0
Medentika TiBase is intended for use with the
Straumann® CARES® System. All digitally designed
abutments for use with Medentika CAD/CAM
Abutments are intended to be manufactured at a
Straumann® CARES® validated milling center. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Medentika Preface CAD/CAM Abutments are intended
for use with dental implants as a support for single or
multiple tooth prostheses in the maxilla or mandible of
a partially or fully edentulous patient.

Implant System
Compatibility Series Implant
Diameter (mm) Platform
Diameter (mm) Nobel Biocare
Replace™ Select E 3.5, 4.3, 5.0, 6.0 3.5, 4.3, 5.0,
6.0 Nobel Biocare
NobelActive™ F 3.0, 3.5, 4.3, 5.0 3.0, 3.5, 3.9
(4.3), 3.9 (5.0) Biomet 3i
Osseotite®
Certain® H 3.25, 4.0, 5.0 3.4, 4.1, 5.0 Biomet 3i
Osseotite® I 3.25, 3.75, 4.0,
5.0 3.4, 4.1, 5.0 Nobel Biocare
Brånemark K 3.3, 3.75, 4.0,
5.0 3.5, 4.1, 4.1,
5.1 Straumann Bone
Level L 3.3, 4.1, 4.8 3.3, 4.1, 4.8 Straumann
Standard N 3.3, 4.1, 4.8 3.5(NNC), 4.8,
6.5 Zimmer Tapered
Screw-vent® R 3.3, 3.7, 4.1,
4.7, 6.0 3.5, 4.5, 5.7 Astra Tech
OsseoSpeed™ S 3.0, 3.5, 4.0,
4.5, 5.0 3.0, 3.5, 4.0,
4.5, 5.0 Dentsply
Friadent®
Frialit/XiVE® T 3.4, 3.8, 4.5, 5.5 3.4, 3.8, 4.5,
5.5
Medentika PreFace is intended for use with the
Straumann® CARES® System. All digitally designed
abutments for use with Medentika CAD/CAM
Abutments are intended to be manufactured at a
Straumann® CARES® validated milling center. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | URIS OMNI Narrow System is
indicated for use in the
treatment of missing maxillary
lateral incisors or the
mandibular central and lateral
incisors, in support of single or
multiple-unit restorations
including: cemented retained,
screw retained, or overdenture
restorations, and final or
temporary abutment support
for fixed bridgework. It is
intended for delayed loading.

The URIS OMNI Prosthetic
abutments are intended for
use with URIS OMNI dental
implants to provide support for
prosthetic restorations such as
crowns, bridges, or over-
dentures.

All digitally designed
abutments and/or coping for
use with URIS OMNI Prosthetic
abutments are intended to be
sent to a TruAbutment-
validated milling center for
manufacture. |

11

Technological Characteristics Comparison Table – Implants

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

12

| Comparison | Subject Device
Kontact™ Dental Implant System
Biotech Dental, SAS | Primary Predicate Device
Kontact™ Dental Implant System
Biotech Dental, SAS
K210220 | Reference Device
Medentika CAD/CAM Abutments
Medentika GmbH
K150203 | Reference Device
URIS OMNI Narrow System & Prosthetic
TruAbutment 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 for
Predicate/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 Abutments
Implant Platform Diameter:
3.6, 4.2, 4.8, 5.4 mm
Prosthetic Platform Ø: 4.0 mm
Angle: 0°, Gingival Height: 1-4 mm
Angle: 17°, Gingival Height: 4 mm
Indexed, non-indexed
Titanium Alloy (ASTM F136) | n/a | Multi-Unit Straight Abutments
PD: 5.0mm
GH: 1.0/2.0/3.0/4.0/5.0/6.0 mm
PH: 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 Diameter
IP = Implant Platform Diameter
GH = Gingival Height
PD = Prosthetic Diameter
(Gingival Diameter)
CA = Post Correction Angle
PH = Post Height
APH = Accessory Post Height
(Multi-Unit Abutments) | 30° Angulated Narrow Conical (indexed) | | n/a | Multi-Unit Angled Abutments
PD: 5.0mm
GH: 4.0/5.0/6.0mm
CA: 29.5
PH: 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 Abutments
Implant Platform Diameter:
3.6, 4.2, 4.8, 5.4 mm
Prosthetic Platform Ø: 4.9 mm
Angle: 17°, Gingival Height: 2-5 mm
Indexed, non-indexed
Titanium Alloy (ASTM F136) | n/a | Multi-Unit Straight Abutments
PD: 5.0mm
GH: 4.0/5.0/6.0mm
CA: 29.5
PH: 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

13

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 13356
Anodized 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 specified
Angle: 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
	Indexed
Titanium 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 mm
Prosthetic Diameter: 5.1, 6.6 mm	Implant Platform Ø: 3.0-7.0 mm
Gingival Height: not specified
	3.6, 4.2, 4.8, 5.4	1, 2, 3, 4, 5	5	30*	4	Gingival Height: 1-5 mm
Angle: 0°
Min PH: 4 mm	Angle: 0 - 30°
Min PH: not specified
Indexed	n/a
	Indexed
Titanium Alloy (ASTM F136), no modified surface
*Max 22° with Kontact Implants					Indexed
Titanium 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 mm
Prosthetic Diameter: 4, 5, 6.5 mm
Gingival 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/coping
Prosthetic Platform Ø: 4.0 mm, 4.9 mm
Gingival 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-Indexed
Grade 5 Titanium Alloy
	PH with Uni-Post Insert 4.9 mm
Titanium 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 - Phynox
Internal Connection	3.0 mm Abutment screw - Phynox
Internal Connection	Internal Connection	Internal Connection
Prosthesis Attachment	Cement-retained
Screw-retained	Cement-retained
Screw-retained	Cement-retained	Multi-unit
Restoration	Single-unit
Multi-unit	Single-unit
Multi-unit	Single-unit
Multi-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