The Biodenta Customized Abutment is 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.

The Biodenta Customized Abutment is compatible with the following implant systems:

-Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Friadent: FRIALIT Implant. XiVA Implant. 3i:Certain Internal Connect Type: Astra: Osseospeed Implant. Osseospeed TX implant; Biohorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVA Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System.

-Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered, Replace Select Straight; for the NP, RP, WP and 6.0 implants. -External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.

Device Description

Biodenta Customized Abutments are titanium abutments designed to be used in coniunction with specific dental implants utilizing the Biodenta customized abutment screws to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch.

The abutment is milled using computer-assisted technology that enables the creation of final abutments that are manufactured with specific geometry. The abutment is made from titanium grade Ti-6AL-4V ELI (meets ASTM standard F-136). The abutment screw and interface is made from titanium grade Ti-6AL-4V ELI (meets ASTM standard F-136).

The Biodenta Customized Abutment is compatible with the following implant systems:

-Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Friadent: FRIALIT Implant, XiVA Implant, 3i:Certain Internal Connect Type; Astra: Osseospeed Implant. Osseospeed TX implant: Biohorizons: Internal Implant System. Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVA Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System.

-Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered. Replace Select Straight; for the NP, RP, WP and 6.0 implants. -External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Biodenta Customized Abutment, based on the provided 510(k) summary:

This device is a physical medical device (dental implant abutment) and therefore does not involve AI/ML technology. The questions regarding AI/ML-specific study design (such as MRMC studies, standalone algorithm performance, training/test set details, expert ground truth establishment for AI/ML models) are not applicable to this submission.

The study described is a non-clinical fatigue testing study to demonstrate mechanical strength and compatibility, and a substantial equivalence comparison to predicate devices, both standard for this type of physical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Strength & Compatibility: Sufficient mechanical strength for intended clinical application and compatibility with specified implant systems, as per ISO 14801.	"Fatigue testing was conducted according to ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for each Biodenta Customized Abutment connection platform. These results show that Biodenta Customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the implant systems for which they are intended."
Substantial Equivalence: Equivalent to predicate devices in intended use, material composition (with noted exceptions for zirconia predicates), fundamental scientific technology, principles of operation, and basic design, raising no new questions of safety or effectiveness.	"Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Customized Abutment is substantially equivalent to the predicate devices in intended use, material composition (except to K072241 and K063734 which are zirconia), fundamental scientific technology, princibles of operation, and basic design. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for Biodenta Customized Abutment."

Acceptance Criteria

Reported Device Performance

Mechanical Strength & Compatibility: Sufficient mechanical strength for intended clinical application and compatibility with specified implant systems, as per ISO 14801.

"Fatigue testing was conducted according to ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for each Biodenta Customized Abutment connection platform. These results show that Biodenta Customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the implant systems for which they are intended."

Substantial Equivalence: Equivalent to predicate devices in intended use, material composition (with noted exceptions for zirconia predicates), fundamental scientific technology, principles of operation, and basic design, raising no new questions of safety or effectiveness.

"Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Customized Abutment is substantially equivalent to the predicate devices in intended use, material composition (except to K072241 and K063734 which are zirconia), fundamental scientific technology, princibles of operation, and basic design. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for Biodenta Customized Abutment."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated as "test set" in the context of clinical data. For the fatigue testing, it's typically understood that a sufficient number of samples (representing the "worst case scenario" for each connection platform) would have been used to meet ISO 14801 requirements. The specific number of abutments tested is not provided.
Data Provenance: The fatigue testing is non-clinical laboratory testing, not human data. The testing was conducted to ISO 14801 standards. The manufacturer is Biodenta Swiss AG, located in Switzerland. The testing was likely conducted in a lab in Switzerland or another accredited facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a physical medical device. Ground truth in this context refers to established engineering standards (ISO 14801) and regulatory definitions of "substantial equivalence," not expert interpretation of clinical data or images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is a physical medical device; there is no "test set" requiring adjudication in the context of reader studies. The evaluation is based on meeting engineering standards and regulatory equivalence.

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 physical medical device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant.

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

Not Applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Engineering Standards: For the fatigue testing, the ground truth is defined by the performance requirements outlined in the ISO 14801 standard.
Regulatory Framework: For substantial equivalence, the ground truth is adherence to the criteria of "intended use, material composition, fundamental scientific technology, principles of operation, and basic design" as compared to legally marketed predicate devices, as assessed by the FDA.

8. The sample size for the training set

Not Applicable. This is a physical medical device; there is no "training set."

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

Not Applicable. This is a physical medical device; there is no "training set."

Summary

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K///0778

510K Summary

JUL 2 9 2011

Owner's name: Biodenta Swiss AG

Address:	Tramstrasse 16
	9442 Berneck.
	Switzerland
Phone:	+41 71 747 11 11
Fax Number:	+41 71 747 11 12

Contact Person: Mr. David Eiler, Regulatory Manager Date Summary prepared: July 29, 2011

Trade name: Biodenta Customized 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):

Company:	Pou Yu Biotechnology Co., Ltd.
Device Name:	TDS Abutment for Nobel Biocare Replace
510(k) number:	K091026
Company:	Pou Yu Biotechnology Co., Ltd.
Device Name:	TDS Titanium Abutment for Nobel Branemark
510(k) number:	K091392
Company:	Friadent GmbH
Device Name:	XiVE TG Abutments
510(k) number:	K032302
Company:	Lifecore Biomedical Inc.
Device Name:	PrimaConnex CAD/CAM Abutment System
510(k) number:	K072241
Company:	Atlantis Components, Inc.
Device Name:	AtlantisTM Abutments in Zirconia for 3i Certain Interface
510(k) number:	K063734

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Indications for Use:

The Biodenta Customized Abutment is 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.

The Biodenta Customized Abutment is compatible with the following implant systems:

Device Description:

The Biodenta Customized Abutment is compatible with the following implant systems:

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Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System.

Non-clinical Testing Data:

Fatigue testing was conducted according to ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for each Biodenta Customized Abutment connection platform. These results show that Biodenta Customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the implant systems for which they are intended.

Equivalence to marketed device:

Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Customized Abutment is substantially equivalent to the predicate devices in intended use, material composition (except to K072241 and K063734 which are zirconia), fundamental scientific technology, princibles of operation, and basic design. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for Biodenta Customized Abutment.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

Biodenta Swiss AG C/O Ms. Angela Blackwell Senior Consultant Biologics Consulting Group Tramstrasse 16 Berneck Switzerland 9442

JUL 2 9 2011

Re: K110778

Trade/Device Name: Biodenta Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 19, 2011 Received: July 20, 2011

Dear Ms. Blackwell:

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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Page 2 - Ms. Blackwell

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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sixon Kunnen

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

Enclosure

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Indications for Use

K110778

510(k) Number (if known): __

Device Name: Biodenta Customized Abutment

Indications for Use:

The Biodenta Customized Abutment is 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.

The Biodenta Customized Abutment is compatible with the following implant systems: - Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Certain Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System.

Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered, Replace Select Straight; for the NP, RP, WP and 6.0 implants.
External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.

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)

urrence of CDRH, Office of Device Evaluation (ODE)

Susan Kumpan

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

510(k) Number: K110778

Page 1 of 1

Revision 2.0
Section 4
Section page 2 of 4

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.)