Biodenta 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.

Device Description

The Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm 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, prosthetic parts and related surgical instruments. The Bone Level D 3.0 to 6.0 mm implants use the same platforms and abutment connections like the Bone Level implants (K111003) for the diameter 4.1. 4.8. and 6.0 mm implants, and therefore the abutments and prosthetic parts of the Bone Level implants are used. The diameter 3.0 mm implants use the same connection concept in a narrower version. The submission includes:

Diameter 3.0 mm Implants with Length of: 10, 12, and 14 mm; Platform B0
Diameter 4.1 and 4.8 mm Implants with Length of: 6.5 mm; Platform B2
Diameter 6.0 mm Implants with Length of: 6.5, 8, 10, and 12 mm; Platform B2
Straight abutments (Straight, Temporary, Ball, Locator); B0 platform, Length 10.4 14.9 mm, Diameter 3.6 - 4.0 mm
Healing abutments, closure screws; B0 platform, Height 0.5 7.1 mm, Diameter 2.8 3.9bmm

AI/ML Overview

The provided text describes a 510(k) Pre-market Notification for the Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm. This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. Therefore, it does not involve a study with acceptance criteria and reported device performance in the typical sense of a diagnostic or AI-driven device.

Here's an analysis of the provided information based on your requested criteria, highlighting what is present and what is not:

Acceptance Criteria and Study for Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm

This 510(k) submission primarily relies on non-clinical testing to demonstrate the substantial equivalence of the Biodenta Dental Implant System to previously marketed predicate devices. The "acceptance criteria" here are defined by the performance in these non-clinical tests, ensuring the device meets safety and effectiveness standards comparable to its predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Mechanical Strength (Fatigue Testing): Sufficient mechanical strength for intended clinical application as per 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 - Bone Level D 3.0 to 6.0 mm has sufficient mechanical strength for their intended clinical application. (Worst-case scenario tested).
Surface Area Comparison: Implant surface area of the new device should be almost identical or higher than the predicate device surface area.	All Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm implant's surface areas are almost identical or higher than the predicate device surface area. Therefore, the surface area is considered sufficient.

Regarding the other requested information (primarily relevant for AI/diagnostic studies):

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented. The testing pertains to physical device properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense is established for this type of device submission. Performance is based on engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. This is a medical device (dental implant), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/diagnostic device. The "truth" for this device is its adherence to mechanical performance standards and material specifications, demonstrated through laboratory testing.
8. The sample size for the training set: Not applicable. There is no "training set" for a physical dental implant.
9. How the ground truth for the training set was established: Not applicable.

Summary of Approach:

The Biodenta Dental Implant System's 510(k) submission demonstrates substantial equivalence primarily through non-clinical test data. This involved:

Fatigue testing: Conducted according to FDA guidance for root-form endosseous dental implants and abutments. This test assessed the mechanical strength under worst-case scenarios, proving it is sufficient for the intended clinical application.
Surface area analysis: Compared the implant surface area of the new device to predicate devices, finding it to be almost identical or higher, which is deemed sufficient.

The submission explicitly states: "Non-clinical test data was used to support the decision of safety and effectiveness." No clinical testing was presented in this summary to support the substantial equivalence. The "acceptance criteria" were met by successfully passing these specified non-clinical performance benchmarks.

Summary

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System – Bone Level D 3.0 to 6.0 mm 5 - 510(k) Summary

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Image /page/0/Picture/1 description: The image shows the logo for "biodenta". The logo consists of the word "biodenta" in a bold, sans-serif font, with a stylized graphic above the word. The graphic appears to be three curved lines stacked on top of each other, resembling a leaf or a wave. There is a small registered trademark symbol to the right of the word "biodenta".

K123512

MAR 2 8 2013

5

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 18, 2013
Trade / proprietary name:	Biodenta Dental Implant System - Bone Level D 3.0 to 6.0mm
Common name:	Endosseous dental implant
Device classification name:	implant, endosseous, root-form
Product code:	DZE
Regulation number:	21 CFR 872.3640
Subsequent Product Code:	NHA (Abutment, Implant, Dental, Endosseous;Regulation #: 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:	Nobel Active 3.0
510(k) number:	K102436

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm 5 - 510(k) Summary

Image /page/1/Picture/1 description: The image shows the word "biodenta" in a bold, sans-serif font. To the right of the word is a small, superscripted "R" in a circle, indicating a registered trademark. Above the word is a stylized graphic that resembles a crescent shape with textured shading, possibly representing a leaf or a dental form.

3. Company:	MIS - Implant Technologies Ltd.	Company	Device Name	10(k) Number	Intended use	Implant Type	Implant to Abut. Connection	Implant Diameter (Length)	Abutment Angle	Implant Material	Abutment Material	Surface Treatment	Sterilization
Device name:ﻤﻴﺮﺍ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ	Seven Implants; Biocom Implants; Lance Implants	Biodenta Swiss AG	Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm	New device	Biodenta 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.	Root-form endosseous dental implant Bone Level Implant	Internal Hexagon	D 3.0 mm (L 10 - 14 mm) D 4.1 mm (L 6.5 mm) D 4.8 mm (L. 6.5 mm) D 6.0 mm (L. 6.5-12 mm)	0°, 15°	Titanium Grade 4	Ti alloy (Ti 6AI 4V)	Spark Anodization	Delivered Sterile Gamma Irradiation
t · 510(k) number:	K103089	Biodenta Swiss AG	Biodenta Dental Implant System - Bone Level	K111003	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.	Root-form endosseous dental implant Bone Level Implant	Internal Hexagon	D 3.5 mm (L 8 - 14 mm) D 4.1 mm (L 8 - 14 mm) D 4.8 mm (L. 8 - 14 mm)	0°, 15°	Titanium Grade 4	Ti alloy (Ti 6AI 4V)	Spark Anodization	Delivered Sterile Gamma Irradiation
4. Company:	Keystone Dental	Nobel Biocare AB	Nobel Active 3.0	K102436	The NobelActive 3.0mm implant is indicated for the use in the treatment of missing maxillary lateral incisors of the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patents. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied	Root-form endosseous dental implant Bone Level Implant	Internal Hexagon	D 3.0 mm (L 10 - 15 mm)	0°, 15°	Titanium Grade 4	Ti alloy (Ti 6AI 4V)	Spark Anodization	Delivered Sterile Gamma Irradiation
age and the country of the consider which while and! Device name:	Genesis Implant System	MIS - Implant Technologies Ltd.	Seven Implants; Biocom Implants; Lance Implants	K103089	MIS dental implants are 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. When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. MIS short implants are to be used only with straight abutment	Root-form endosseous dental implant Bone Level Implant	Internal Hexagon	D 4.0 (L 6 mm) D 5.0 (L 6 mm) D 6.0 (L 6 mm)	0°, 15°, 20°, 25°	Ti alloy (Ti 6AI 4V)	Ti alloy (Ti 6AI 4V)	Sand blasted and acid etched	Delivered Sterile Gamma Irradiation
510(k) number:	K101545	Keystone Dental	Genesis Implant System	K101545	The Genesis Implant System is intended for use in single-stage or two-stage surgical procedures in all types of bone in partially or fully edentulous mandibles and maxillae. The Genesis Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established and appropriate occlusal loading is applied.	Root-form endosseous dental implant Bone Level Implant	Internal 6 lobe	D 3.8 mm (L 8.5 - 18 mm) D 4.5 mm (L 8.5 - 18 mm) D 5.5 mm (L 8.5 - 16 mm) D 6.5 mm (L 8.5 - 13 mm)	0°, 15°	Ti alloy (Ti 6AI 4V)	Ti alloy (Ti 6AI 4V)	Double-acit-etching & Spark Anodization	Delivered Sterile Gamma Irradiation

Indications for Use:

Device Description:

Diameter 3.0 mm Implants with Length of: 10, 12, and 14 mm; Platform B0
Diameter 4.1 and 4.8 mm Implants with Length of: 6.5 mm; Platform B2
Diameter 6.0 mm Implants with Length of: 6.5, 8, 10, and 12 mm; Platform B2
Straight abutments (Straight, Temporary, Ball, Locator); B0 platform, Length 10.4 14.9 mm, Diameter 3.6 - 4.0 mm
Healing abutments, closure screws; B0 platform, Height 0.5 7.1 mm, Diameter 2.8 3.9bmm

Non-clinical Testing Data:

Fatique 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 - Bone Level D 3.0 to 6.0 mm implants and abutments was tested. The results show that the Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm has sufficient mechanical strength for their intended clinical application.

To compare the implant surface area of the Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm with the predicate devices an implant surface area analysis has been carried out. All Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm implant's surface areas are almost identical or higher than the predicate device surface area. Therefore the surface area is considered to be sufficient.

Clinical Testing:

Non-clinical test data was used to support the decision of safety and effectiveness.

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 D 3.0 to 6.0 mm 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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Image /page/2/Picture/1 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 word. Above the word is a curved, stylized graphic element that appears to be made of three curved lines.

Summary Substantial Equivalence Comparison to predicate devices:

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System – Bone Level D 3.0 to 6.0 mm 5 - 510(k) Summary

Image /page/3/Picture/1 description: The image shows the logo for "biodenta". The logo consists of the word "biodenta" in a sans-serif font, with a stylized graphic above it. The graphic appears to be three curved lines stacked on top of each other, creating a semi-circular shape. A registered trademark symbol is present to the right of the word "biodenta".

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 28, 2013

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

Re: K123512

Trade/Device Name: Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: February 19, 2013 Received: February 21, 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 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 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 (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/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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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for

Anthony D. Watson, B.S., M.S., M.B.A. Director 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 - Bone Level D 3.0 to 6.0 mm 4 - Indications for Use Statement

Image /page/6/Picture/1 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 word. Above the word is a graphic of what appears to be a stylized leaf or feather design.

Indications for Use

K 123512 510(k) Number (if known):

Device Name: Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm

Indications for Use:

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)

Mary S. Runner -S
Susan Runner, DOSMA
2013:03.21
12:14:28 -04'00'

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

510(k) Number:

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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.