TDS Abutment for Friadent Xive 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.

This device is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok® 3.0 implant system; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Implant.

Device Description

TDS Abutment for Friadent Xive are titanium and ceramic-titanium abutments designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used 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. TDS Abutment for Friadent Xive is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BirHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok 3.0 implant system; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Impalnt.

AI/ML Overview

The provided document describes the K103339 510(k) Premarket Notification for the "TDS Abutment for Friadent Xive." This device is a dental implant abutment.

Here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Strength	Mechanical testing, according to ISO 14801 Dentistry - Fatigue test for endosseous dental implants, was conducted on a worst-case scenario with an angle abutment. Result: The testing results show that TDS Abutment for Friadent Xive made of titanium, zirconia-titanium, and zirconia materials for their respective dental implant systems have sufficient mechanical strength for their intended clinical application.
Compatibility with Implant Systems	Compatibility testing was conducted on the abutments and corresponding dental implants with designated screws. The dimensions, tolerances, and rotation parameters were evaluated to determine appropriate fit. Result: The testing results show that TDS Abutment for Friadent Xive is compatible with the implant systems for which it is indicated for use (listed in the "Intended Use" section: Firadent, 3i, Astra, BioHorizons, Lifecore, Zimmer, Osstem, Nobel Biocare systems with internal hex ≥ 1.78mm flat-to-flat dimensions).
Material Equivalence (Implicit)	The device incorporates "the same materials" as predicate devices (Ti-6Al-4V ELI and Y-TZP Zirconia for abutment, Ti-6Al-4V ELI for screw if provided by manufacturer).
Design and Operating Principle Similarity	The device "incorporates the same basic design" and "uses the same operating principle" as predicate devices.
Manufacturing Process Similarity	The device "is produced using the same processes" as predicate devices.
Intended Use Equivalence	The device "has the same intended use" as predicate devices. (Support for single or multiple tooth prostheses in maxilla or mandible of partially or fully edentulous patients).

Summary of Study: The primary study conducted was non-clinical testing focusing on mechanical strength and compatibility.

The document does not suggest an AI/ML device. Therefore, the following points are not applicable to the provided information.

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

Not applicable, as this is a mechanical medical device, not an AI/ML device, and no clinical data (test set) is described in the provided summary. The testing was non-clinical.

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, as this is a mechanical medical device, not an AI/ML device. Ground truth, in the context of expert consensus for medical imaging, is not relevant here. The "ground truth" for mechanical performance is established by standardized testing protocols (ISO 14801).

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

Not applicable, as this is a mechanical medical device, not an AI/ML device with a human-adjudicated test set.

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, as this is a mechanical medical device and not related to AI assistance for human readers.

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

Not applicable, as this is a mechanical medical device and not an algorithm.

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

For the mechanical strength testing, the "ground truth" or the success criteria would be defined by the acceptance limits specified in the ISO 14801 Dentistry - Fatigue test for endosseous dental implants standard. For compatibility testing, the "ground truth" is appropriate fit based on measured dimensions, tolerances, and rotation parameters. This is a technical standard-based ground truth.

8. The sample size for the training set

Not applicable, as this is a mechanical medical device and not an AI/ML device that requires a training set.

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

Not applicable, as this is a mechanical medical device and not an AI/ML device.

Summary

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K103339

510(k) Summary Pou Yu Biotechnology Co., Ltd TDS Abutment for Friadent Xive

APPLICANT'S NAME AND ADDRESS

Applicant' Name: Address:

Telephone: Fax: Official Contact: Date Prepared:

Pou Yu Biotechnology Co., Ltd. No. 6 Fugong Rd. Fusing Township Changhua County 506, Taiwan +886-(0)4 768 5660 x5122 +886-(0)4 768 9032 Daniel Tsao November 5, 2010

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

Product Code: Classification Panel: Reviewing Branch:

TDS Abutment for Friadent Xive, Dental implant abutment Endosseous dental implant abutment Class II, 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch

LEGALLY MARKETED DEVICES

FRIADENT GmbH. – Xive TG Abutments –K032302 Lifecore Biomedical Inc. - PrimaConnex® CAD/CAM Abutment System- K072241 Atlantis Components, Inc. - Atlantis M Abutment in Zirconia for 3i Certain Interface- K063734.

DEVICE DESCRIPTION

Confidential

MAR 3 1 2011

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the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutment for Friadent Xive is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BirHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok 3.0 implant system; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Impalnt.

INTENDED USE OF THE DEVICE

ﺑ

TDS Abutment for Friadent Xive 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.

This device is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALJT Implant, XiVA Implant; 3i: Internal Connect Type: Astra: Osseospeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok 3.0 implant system: Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Implant.

TECHNOLOGICAL CHARACTERISTICS

TDS Abutment for Friadent Xive has the following similarities to the predicate devices which have been determined by FDA:

· has the same intended use,
· uses the same operating principle,
· incorporates the same basic design,
· incorporates the same materials, and
· is produced using the same processes.

The basis for Pou Yu Biotechnology Co. Ltd.'s belief that TDS Abutment for Friadent Xive is substantially equivalent to the predicate devices is summarized in the following table.

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510(k) Premarket Notification

	Subject DevicePou Yu Biotechnology Co.TDS Abutment for Friadent Xive	FRIADENT GmbH.XIVE TG AbutmentsK032302	Predicate DevicesLifecore Biomedical Inc.PrimaConnex® CAD/CAMAbutment SystemK072241	Atlantis Components, Inc.Atlantis™ Abutment in Zirconia for 3iCertain InterfaceK063734
Intended use	TDS Abutment for Friadent Xive isintended for use with dental implantsas a support for single or multipletooth prostheses in the maxilla ormandible of a partially or fullyedentulous patient.TDS Abutment for Friadent Xive iscompatible with the following implantsystems which have an internal hexwith flat-to-flat dimensions of1.78mm or greater: Firadent:FRIALIT Implant, XiVA Implant; 3i:Internal Connect Type; Astra:Osseospeed Implant, Osseospeed TXImplant; BioHorizons: InternalImplant System, Tapered InternalImplant System, Single-Stage ImplantSystem, Laser-lok® 3.0 implantsystem; Lifecore: LifecoreRENOVAT™ Internal Hex ImplantSystem; Zimmer: TaperedScrew-Vent Implant System,Screw-Vent Implant System, AdVentImplant System; Osstem: GS System;Nobel Biocare: Active Impalnt.	The XIVE TG Abutment isintended for use in the fabricationof screw-retained and cementablecrowns and bridges.	The Lifecore PrimaConnex®CAD/CAM Abutment System isintended for use as an accessory to aLifecore PrimaConnex endosseousimplant to support a prostheticdevice in a partially or completelyedentulous patient. It is intended foruse to support single and multipletooth prostheses in the mandible ormaxilla. The prosthesis can becement retained to the abutment.The abutment screw is intended tosecure the abutment to theendosseous implant. The copings areintended for use as a core structurefor a prosthetic restoration inpartially or fully edentulousmandibles or maxillae in theconstruction of single-unit cementretained restorations on LifecorePrimaConnex CAD/CAMAbutments.	The devices covered by this submission areabutments which are placed into a dentalimplant to provide support for a prostheticreconstruction. The Atlantis Abutment isintended for use as an accessory to anendosseous implant to support a prostheticdevice in a partially or completely edentulouspatient. It is intended for use to supportsingle and multiple tooth prosthesis, in themandible or maxilla. The prosthesis can becement retained to the abutment. Theabutment screw is intended to secure theabutment to the endosseous implant. Pleasenote: Highly angled abutments (i.e. 30degrees) on implants with diameters less than4 mm are intended for the anterior region ofthe mouth and are not intended for theposterior region due to the limited strength ofthe implant fixture.
Custom Design
Attachment	Implant level	Implant level	Implant level	Implant level
Restoration	Cement-retained	Cement-retained	Cement-retained	Cement-retained
CAD/CAMprocessing	Yes	Yes	Yes	Yes
Material
Abutment	Ti-6Al-4V ELI;Y-TZP Zirconia	Ti-6Al-4V ELI	Y-TZP Zirconia	Y-TZP Zirconia
Screw	Provided by Pou Yu BiotechnologyCo. Ltd.	Provided by individualmanufacturers for specifiedimplants	Provided by individualmanufacturers for specified implants	Provided by Atlantis Components, Inc.

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NON-CLINICAL TESTING DATA

Mechanical testing, according to ISO 14801 Dentistry - Fatigue test for endosseous dental implants, was conducted on a worst-case scenario with construction of an angle abutment to ensure that the strength of TDS Abutment for Friadent Xive is appropriate for its intended use.

Compatibility testing was conducted on the abutments and corresponding dental implants with designated screws, the dimensions, tolerances and rotation parameters were evaluated in determining appropriate fit.

These testing results show that TDS Abutment for Friadent Xive made of titanium, zirconia-titanium and zirconia materials for their respective dental implant systems have sufficient mechanical strength for their intended clinical application and are compatible with the implant systems for which they are indicated for use.

CONCLUSION

Pou Yu Biotechnology Co. Ltd demonstrated that, for the purposes of FDA's regulation of medical devices, TDS Abutment for Friadent Xive is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Mr. Daniel Tsao Pou Yu Biotechnology Company, Limited No. 6, Fugong Road Fusing Township, Changhua City China Taiwan 506

MAR 3 1 2011

Re: K103339

Trade/Device Name: TDS Abutment for Friadent Xive Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment · Regulatory Class: II Product Code: NHA Dated: March 17, 2011 Received: March 17, 2011

Dear Mr. Tsao:

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- Mr. Tsao

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hh 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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510(k) Premarket Notification

Indications for Use

103339 510(k) Number (if known):

Device Name: TDS Abutment for Friadent Xive

Indications for Use:

TDS Abutment for Friadent Xive 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.

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, Qffice of Device Evaluation (ODE)

Susan Kurpe

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

Page 1 of 1

510(k) Number: K103339

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.)