Biodenta bone level dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

Device Description

The Biodenta Dental Implant System - Bone Level is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and prosthetic parts and related surgical instruments.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Biodenta Dental Implant System - Bone Level. This document primarily focuses on demonstrating substantial equivalence to predicate devices and includes non-clinical testing data (fatigue testing). It does NOT describe an AI/ML powered medical device, nor does it contain information regarding acceptance criteria or a study that typically involves these concepts for AI/ML devices.

Therefore, the requested information cannot be extracted from the provided text as it pertains to a traditional medical device (dental implant) that does not utilize AI/ML.

Here's why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: Not applicable. The document discusses "sufficient mechanical strength" based on fatigue testing, but there are no specific numerical acceptance criteria or performance metrics in a table format that would typically be associated with AI/ML device evaluations (e.g., sensitivity, specificity thresholds).
Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical dental implants used in fatigue testing, not a dataset for an AI model. The document mentions "worst case scenario" for the implants but no sample size for a test set in the context of AI.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts on a dataset. This is irrelevant for a physical dental implant.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve disagreements among experts on ground truth for AI datasets. This is not mentioned as the device is not AI-powered.
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. MRMC studies are specific to evaluating AI's impact on human performance in diagnostic tasks. This device is an implant, not a diagnostic tool assisted by AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to the performance of an AI algorithm on its own. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for AI is not relevant here. The "proof" for this device lies in its physical properties and mechanical strength demonstrated through non-clinical testing.
The sample size for the training set: Not applicable. This device does not involve a training set for an AI model.
How the ground truth for the training set was established: Not applicable. This device does not involve a training set for an AI model.

Summary

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SEP 1 5 2011

510(k) Summary

Biodenta Swiss AG Owner's name: Tramstrasse 16 9442 Berneck Address: Switzerland Phone: +41 71 747 11 11 + 41 71 747 11 12 Fax number: Contact person: Mr. David Eiler, Regulatory Manager Date summary prepared: April 8, 2011 Trade / proprietary name: Biodenta Dental Implant System - Bone Level Endosseous dental implant Common name: Device classification name: implant, endosseous, root-form Product code: DZE Regulation number : 21 CFR 872.3640 NHA (Regulation number: 21 CFR 872.3630) Subsequent Product Code: Legally marketed device to which equivalence is claimed (predicate device): Company: Biodenta Swiss AG Biodenta Dental Implant System Device name: K093630 510(k) number: Nobel Biocare Ab Company: Device name: Nobelactive Internal Connection Implant K071370 510(k) number:

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Indications for Use:

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 and ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants. The worst case scenario for the Biodenta Dental Implant System - Bone Level implants and abutments was tested. These results show that Biodenta Dental Implant System - Bone Level have sufficient mechanical strength for their 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 - Bone Level is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the Biodenta Dental Implant System - Bone Level.

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Substantial Equivalence Comparison to predicate device:

	Subject Device	Predicate Devices
Device	Biodenta Dental ImplantSystem - Bone Level	Biodenta Dental ImplantSystem (K093630)	Nobelactive Internal ConnectionImplant (K071370)
Intended use	Biodenta bone level dentalimplants are intended forsurgical placement inmandibles or maxillae tosupport single or multipletooth restorations orterminal or intermediateabutment support for fixedor removable bridgeworkand to retain overdentures.	Biodenta dental implantsare intended forsurgical placement inmandibles or maxillae tosupport single or multipletooth restorations orterminal or intermediateabutment support for fixedor removable bridgeworkand to retain overdentures.Specific indications for smalldiameter (Ø 3.5 mm)implants: It is recommendednot to place small implantswith "NP" platform in themolar or premolar region.	Nobel Biocare's NobelActiveimplants are endosseous implantintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such as anartificial tooth, in order to restorepatient esthetics and chewingfunction. Nobel Biocare'sNobelActive implants are indicatedfor single or multiple unitrestorations in splinted or non-splinted applications. NobelBiocare's NobelActive implants maybe placed immediately and put intoimmediate function provided thatinitial stability requirements detailedin the manual are satisfied.
System	threaded, root-form dentalimplant, bone level	threaded, root-form dentalimplant, tissue level	threaded, root-form dentalimplant, bone level
Diameter	3.5 mm, 4.1 mm, 4.8 mm	3.5 mm, 4.1 mm, 4.8 mm	3.5 mm, 4.3 mm, 5.0 mm
Connection	Internal Hexagon	Internal Octagon	Internal Hexagon
ImplantMaterial	Titanium	Titanium	Titanium
AbutmentSystem	Angled Abutment	Angled Abutment	Angled Abutment
AbutmentAngle	0°, 15°	0°, 15°, 20°	0°, 15°
AbutmetMaterial	Titanium Alloy	Titanium Alloy	Titanium Alloy

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

SEP 15 2011

Re: K111003

Trade/Device Name: Biodenta Dental Implant System - Bone Level Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 9, 2011 Received: September 12, 2011

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 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. 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 vou, 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 Eederal 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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/McdicalDevices/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.

Sincerely vours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Biodenta Dental Implant System - Bone Level

Indications for Use:

Biodenta bone level dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

Prescription Use X (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)

Susan Rumm

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

510(k) Number: K111003

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Revision 1.1 Section な 2 01 4 Section page

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.