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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.

Device Description

The Kontact™ Dental Implant System comprises endosseous root-form dental implants, abutments, abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations. Kontact dental implants are provided in five body diameters: 3.0 mm, 3.6 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The platform diameter for each size is the same as the (maximum) body diameter. The implants are provided in lengths ranging from 8 mm to 16 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. All implants are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. The endosseous threaded surface of the subject device implants is grit-blasted with non-resorbable aluminum oxide (Al2O3) particles. Kontact conventional and prosthetic components include cover screws, abutment screws, temporary abutments, straight abutments, angled abutments, prepable abutments, multi-unit abutments, healing caps, and overdenture abutments. Most device screws and all subject device abutments are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. Select subject device abutments and screws manufactured from titanium alloy are anodized using standard electrolytic passivation processing to impart a distinctive surface color. The subject device abutment screw intended for 3 mm diameter implants and the prosthesis screw intended for conical abutments are manufactured from cobalt alloy, conforming to ASTM F1058 and ISO 5832-7. The abutment screw is coated with titanium nitride (TiN); the prosthesis screw is coated with chromium nitride (CrN). Subject device healing caps intended for use with UniPost abutments, and IsoPost abutments are manufactured from polyetheretherketone (PEEK). Subject device healing caps intended for NanoPost abutments and IsoPost abutments are manufactured from polymethyl methacrylate (PMMA).

AI/ML Overview

The product, Kontact™ Dental Implant System, has not reported any clinical studies. The only data provided is non-clinical performance data.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Evaluation Type	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Conformance to ISO 10993-5 and ISO 10993-12	Device demonstrates biocompatibility according to ISO 10993-5 (tests for in vitro cytotoxicity) and ISO 10993-12 (sample preparation and reference materials). Specific results are not detailed but compliance with these standards indicates meeting requirements for biological safety.
Gamma Sterilization	Conformance to ISO 11137-1 and ISO 11137-2	Validation performed for subject device implants and cover screws. Specific Sterility Assurance Levels (SAL) are not stated, but conformance to these standards implies achieving a validated sterile state (e.g., SAL of 10^-6).
Bacterial Endotoxin Testing (BET)	≤ 20 EU/device	Limulus amebocyte lysate (LAL) test performed according to ANSI/AAMI ST72 and USP 43-NF38:2020 . Ongoing monitoring and control ensure BET levels meet or are below ≤ 20 EU/device. This indicates the devices are free from pyrogenic contamination within accepted limits.
Shelf Life Validation	Conformance to ASTM F1980 and ISO 11607-1	Packaging stability validated. Conformance to ASTM F1980 (standard guide for accelerated aging of sterile medical device packages) and ISO 11607-1 (packaging for terminally sterilized medical devices) indicates the device maintains its integrity and sterility over its claimed shelf life. Specific shelf life duration is not provided.
Moist Heat Sterilization (End-user)	Conformance to ISO 17665-1 and ISO TS 17665-2	Instructions and validation for end-user moist heat sterilization provided. Conformance to ISO 17665-1 (sterilization of health care products - moist heat - requirements for the development, validation and routine control of a sterilization process for medical devices) and ISO TS 17665-2 (guidance on the application of ISO 17665-1) ensures proper sterilization by the end-user. Specific parameters are not detailed.
Static Compression & Compression Fatigue Testing	Conformance to ISO 14801	Mechanical performance testing performed on the subject device according to ISO 14801 (dentistry - implants - dynamic fatigue test for endosseous dental implants). The fatigue limit data for abutments compatible with 3.0 mm diameter implants was supported by reference device K183518, and "constructs of all other subject device abutments in combination with all other subject device implants have sufficient strength for their intended use." This indicates the devices meet mechanical strength requirements for their intended application. The specific criteria for "sufficient strength" are not explicitly quantified (e.g., number of cycles survived, load at failure) but implied by conformance to the standard.
Endosseous Surface Characterization	Demonstrated by SEM and EDS	The grit-blasted surface (with non-resorbable aluminum oxide) was validated by scanning electron microscope (SEM) and energy dispersive X-ray spectroscopy (EDS) characterization. This confirms the presence and composition of the surface modification intended to facilitate osseointegration.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for any of the non-clinical tests.
Data Provenance: All data is non-clinical and derived from laboratory testing of the device and its components, primarily referencing international and industry standards (ISO, ASTM, ANSI/AAMI, USP). Information on the country of origin of the test data is not provided, but the manufacturer is Biotech Dental, SAS, based in France. The data is retrospective in the sense that it's generated as part of a premarket submission, not from a prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device relies on pre-defined engineering and sterility standards, not expert-established ground truth from clinical cases. There were no clinical studies.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. There was no test set for clinical performance requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. No clinical studies were conducted, and this product does not involve AI or human reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This product is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

Not applicable. Ground truth, in the clinical sense, was not used as there were no clinical studies. The "ground truth" for non-clinical testing is adherence to established international and industrial standards (e.g., ISO, ASTM) for material properties, mechanical performance, and sterility.

8. The Sample Size for the Training Set

Not applicable. There was no training set, as this is a physical medical device and not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There was no training set.

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