Biodenta Dental Implant System Multi Use Abutments are intended for terminal or intermediate abutment support for fixed or removable crown, bridgework and to retain overdentures.

Device Description

The Biodenta Dental Implant System - Multi-Use Abutment is an extension to the Biodenta Dental Implant System Bone Level (K111003), which is an integrated system of endosseous dental implants, abutments and prosthetic parts and related surgical instruments.

The Biodenta Dental Implant System - Multi-Use Abutment includes 0°, 18°, and 30° abutments for screw retained restorations. Each angulation is available with 2, 3, 4, and 5 mm cuff height for both Biodenta Bone Level implant platform types (B1 and B2). The angulated abutments include hexed and non-hexed versions for single unit or multi unit restorations respectively. Abutment diameters are from 4.5 - 5.0 mm.

The system includes a ball attachment abutment with a diameter of 4.5 mm and height of 5.5 mm, and temporary abutments with a diameter of 4.0 mm and height of 12.5 mm, which are to be attached onto the Multi-Use Abutment. Burn out cylinders are provided. The system includes 2 diameters of abutment and 1 diameter of prosthetic screws. Short and long impression posts for open and closed tray impression taking, and a protective cap for the Multi-Use Abutment is included.

AI/ML Overview

The provided 510(k) summary does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically seen for AI/ML devices (e.g., sensitivity, specificity, AUC). Instead, this submission is for a dental implant abutment, and its "acceptance" is based on demonstrating substantial equivalence to a predicate device through non-clinical mechanical testing and comparison of design features and intended use.

Here's an breakdown based on the information provided, highlighting what is present and what is absent regarding acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Sufficient mechanical strength for intended clinical application (according to FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments)	The results show that the Biodenta Dental Implant System - Multi Use-Abutment has sufficient mechanical strength for the intended clinical application.
Substantial equivalence to predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design.	Biodenta Swiss AG demonstrated that the device is substantially equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated. The "worst case scenario" was tested for fatigue, implying a limited number of test units were subjected to mechanical loading.
Data Provenance: The testing was conducted internally by Biodenta Swiss AG. This is a non-clinical, in-vitro study (mechanical testing), not a study involving human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the "ground truth" for a mechanical strength test is the material's failure point under a specific load, determined by engineering standards and equipment, not human experts.

4. Adjudication method for the test set

Not applicable. The test results are objective measurements from mechanical testing.

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

No. This is a submission for a physical medical device (dental implant abutment), not an AI/ML diagnostic software. Therefore, an MRMC study is not relevant or performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the mechanical load and cycle count at which the device fails, compared against established engineering standards and guidelines for dental implant abutments (specifically, the FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments).

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical device and not an AI/ML model.

9. How the ground truth for the training set was established

Not applicable. No training set for an AI/ML model is involved.

Summary of the Study:

The primary study mentioned is fatigue testing conducted according to the "FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff." This is a non-clinical, in-vitro mechanical test. The study design focused on a "worst case scenario" for the Biodenta Dental Implant System - Multi Use-Abutment and implant. The purpose of this testing was to demonstrate that the device possesses sufficient mechanical strength for its intended clinical application, thereby supporting its substantial equivalence to predicate devices. The study did not involve human subjects, AI/ML algorithms, or expert adjudication for its results.

Summary

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Multi-Use Abutment 5 - 510(k) Summary

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Image /page/0/Figure/2 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers '1', '2', '3', '4', '9', and '1'. The numbers are written in a cursive style, with some of the numbers connected to each other.

MAY 3 0 2013

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510(k) Summary

Owner's name:	Biodenta Swiss AG
Address:	Tramstrasse 169442 BerneckSwitzerland
Phone:	+41 71 747 11 11
Fax number:	+ 41 71 747 11 12
Contact person:	Mr. David Eiler, Regulatory Manager
Date summary prepared:	February 26, 2013
Trade / proprietary name:	Biodenta Dental Implant System - Multi-Use Abutment
Common name:	Endosseous dental implant abutment
Device classification name:	Abutment, Implant, Dental, Endosseous
Product code:	NHA
Regulation number:	21 CFR 872.3630

Legally marketed device to which equivalence is claimed (predicate device):

1. Company:	Biodenta Swiss AG
Device name:	Biodenta Dental Implant System – Bone Level
510(k) number:	K111003
2. Company:	Nobel Biocare AB
Device name:	NobelActive Multi Unit Abutment
510(k) number:	K072570

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K123491

Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Multi-Use Abutment 5 - 510(k) Summary

Image /page/1/Picture/2 description: The image shows the logo for "biodenta." The logo consists of the word "biodenta" in a bold, sans-serif font, with a registered trademark symbol to the right of the "a." Above the word is a graphic of three curved lines, resembling a stylized wave or swoosh design. The overall design is simple and modern.

3. Company:	Biomet 3i
Device name:	Low Profile Abutment
510(k) number:	K092341

Indications for Use:

Biodenta Dental Implant System Multi Use Abutments are intended for terminal or intermediate abutment support for fixed or removable crown, bridgework and to retain overdentures.

Device Description:

Non-clinical Testing Data:

Fatigue testing was conducted according to FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff. The worst case scenario for the Biodenta Dental Implant System - Multi Use-Abutment and implant was tested. The results show that the Biodenta Dental Implant System - Multi Use-Abutment has sufficient mechanical strength for the intended clinical application.

Equivalence to marketed device:

Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Dental Implant System - Multi-Use Abutment is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design.

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System – Multi-Use Abutment 5 - 510(k) Summary

Image /page/2/Picture/2 description: The image shows the word "biodenta" in a bold, sans-serif font. Above the word is a stylized graphic of three curved lines, resembling a stylized leaf or wave. To the right of the word "biodenta" is a small, superscripted "R" in a circle, indicating a registered trademark.

Summary Substantial Equivalence Comparison to predicate devices:

	Subject Device		Predicate Devices
Company	Biodenta Swiss AG	Biodenta Swiss AG	Nobel Biocare AB	Biomet 3i
Device Name	Biodenta DentalImplant System -Multi-Use Abutment	Biodenta DentalImplant System -Bone Level	NobelActive MultiUnit Abutment	Low Profile Abutment
510(k)Number	New device	K111003	K072570	K092341
Intended use	Biodenta DentalImplant System MultiUse Abutments areintended for terminalor intermediateabutment support forfixed or removablecrown, bridgeworkand to retainoverdentures.	Biodenta bone leveldental implants areintended for surgicalplacement inmandibles or maxillaeto support single ormultiple toothrestorations or terminalor intermediateabutment support forfixed or removablebridgework and toretain overdentures.	NobelActive Multi UnitAbutment is a pre-manufacturedprosthetic componentdirectly connected tothe endosseousdental implant and isintended for use asan aid in prostheticrehabilitation.	BIOMET 3i Low ProfileAbutments are intended foruse as accessories toendosseous dental implantto support a prostheticdevice in a partially orcompletely edentulouspatient. A dental abutment isintended for use to supportsingle and multiple toothprosthesis, in the mandibleor maxilla. The prosthesis isscrew retained to theabutment.
Restorations	Screw retained	Screw retained &cemented	Screw retained	Screw Retained
AbutmentType	Straight & Angled	Straight & Angled	Straight & Angled	Straight & Angled
AbutmentAngle	0°, 18°, 30°	0° - 15°	0°, 17°, 30°	0°, 17°, 30°
Implant toAbut. Connect	Internal Hexagon	Internal Hexagon	Internal Hexagon	Internal Hexagon
Abutmentfixation	Abutment Screw	Abutment Screw	Abutment Screw	Abutment Screw
CompatibleImplantsDiameter	3.5 mm4.1 mm4.8 mm	3.5 mm4.1 mm4.8 mm	3.5 mm4.3 mm5.0 mm	3.25 mm4.0 mm5.0 mm6.0 mm
Abutmentcuff height	2.0 - 5.0 mm ( 0°)2.2 - 5.2 mm (18°)2.0 - 5.0 mm (30°)	5.7 - 9.8 mm	1.5 - 4.5 mm ( 0°)2.5 - 3.5 mm (17°)3.5 - 4.5 mm (30°)	1.0 - 4.0 mm ( 0°)2.0 - 4.0 mm (17°)3.0 - 5.0 mm (30°)
AbutmentMaterial	Titanium Alloy	Titanium Alloy	Titanium Alloy	Titanium Alloy
Sterilization	Deliverednon sterile	Deliverednon sterile	Deliverednon sterile	Deliverednon sterile
Reusable	No	No	No	No

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Premarket Notification / 510(k) Submission . Biodenta Dental Implant System - Multi-Use Abutment 5 - 510(k) Summary ،

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 30, 2013

Mr. David Eiler Regulatory Manager Biodenta Swiss AG Tramstrasse 16 Berneck, Switzerland 9442

Re: K123491

Trade/Device Name: Biodenta Dental Implant System Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 15. 2013 Received: May 16, 2013

Dear Mr. Eiler:

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 Eederal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Eiler

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Image /page/5/Picture/7 description: This image shows a letter that is signed by Mary S. Runner and Kwame Ulmer. The letter is signed digitally by Mary S. Runner on May 30, 2013, at 11:26:12 -04'00'. Kwame Ulmer is the Acting Director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health.

Enclosure

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Multi-Use Abutment 4 - Indications for Use Statement

Image /page/6/Picture/1 description: The image shows the logo for "biodenta". Above the word "biodenta" is a graphic of three curved lines stacked on top of each other. To the right of the word "biodenta" is a circled R symbol.

Indications for Use

510(k) Number (if known): _K123491

Device Name: Biodenta Dental Implant System - Multi-Use Abutment

Indications for Use:

Biodenta Dental Implant System Mutti-Use Abutments are intended for terminal or intermediate abutment support for fixed or removable crown, bridgework and to retain overdentures.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

by Mary S. Runner - S Mary S. Ru COLLA 2300.100.1.1=1300087950 ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ દિવેલ 2013.05.30 09:59:13 -04'00

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

417349 510(k) Number,

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Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)