Denracle Dental Abutment for Osstem GS Implant 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 system: OSSTEM GS Fixture System Ø 4.0 mm, Ø 4.5 mm and Ø 5.0 mm.

Device Description

Denracle Dental Abutment for Osstem GS Implant are titanium abutments designed to be used in conjunction with specific dental implants utilizing the Dental 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. Denracle Dental Abutment for Osstem GS Implant is compatible with the following implant systems: OSSTEM GS Fixture System 04.0 mm, Ø4,5 and Ø5,0mm.

AI/ML Overview

This looks like a 510(k) summary for a dental abutment, which is a medical device, not a software device. Therefore, the questions about AI performance, multi-reader multi-case studies, and ground truth establishment for software training and testing sets are not applicable.

However, I can extract the information relevant to the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.

Here's a breakdown of the available information:

Acceptance Criteria and Device Performance

The provided document describes a "Denracle Dental Abutment for Osstem GS Implant" and focuses on demonstrating its substantial equivalence to a legally marketed predicate device (TDS Abutment for Friadent Xive - K103339). The acceptance criteria are primarily related to mechanical strength and compatibility for its intended use, rather than performance metrics for a diagnostic or AI-driven device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Mechanical Strength	ISO 14801 Dentistry - Fatigue test for endosseous dental implants (worst-case scenario)	"sufficient mechanical strength for their intended clinical application" (acceptable results)
Material Biocompatibility	Biocompatibility testing	"acceptable results"
Sterilization	Sterilization process testing	"acceptable results"
Compatibility/Fit	Dimensions, tolerances, and rotation parameters with corresponding dental implants and screws	"compatible with the implant system for which they are indicated for use" (evaluated and found appropriate)
Substantial Equivalence	Same intended use, operating principle, basic design, materials, and production processes as predicate device (TDS Abutment for Friadent Xive)	Device deemed "substantially equivalent" to predicate device by FDA for indications and design principles.

2. Sample Size and Data Provenance for Test Set:

Sample Size for Test Set: Not explicitly stated. The document mentions "testing was conducted on a worst-case scenario" for mechanical testing, implying specific test articles were used, but the quantity isn't provided.
Data Provenance: The testing was conducted internally by Green DenTech Co., Ltd. (the manufacturer) as part of their 510(k) submission. No information about country of origin of data or retrospective/prospective nature is applicable in the context of device mechanical and material testing.

3. Number of Experts and Qualifications for Ground Truth:

This concept is not applicable for this type of medical device submission. Ground truth, in the context of AI, refers to expert-validated labels or diagnoses. For a dental abutment, the "ground truth" is established through engineering standards (e.g., ISO 14801) and material science principles, which are verified through objective laboratory testing.

4. Adjudication Method:

This is not applicable. The testing involves objective measurements against established engineering standards, not subjective interpretation requiring adjudication among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the purpose of this device.

6. Standalone Performance Study:

Yes, a form of "standalone" performance was effectively done in the form of the non-clinical mechanical, biocompatibility, and sterilization testing. These tests evaluate the device's inherent properties and performance against predetermined standards, independent of human interaction beyond operating the testing equipment.

7. Type of Ground Truth Used:

The "ground truth" for this device's evaluation is based on established engineering standards (e.g., ISO 14801), material science principles, and predefined specifications for compatibility and fit. These are objective benchmarks against which the device's test results are compared.

8. Sample Size for Training Set:

This concept is not applicable. There is no "training set" as this is a physical medical device, not an AI algorithm that undergoes machine learning training.

9. How Ground Truth for Training Set was Established:

This concept is not applicable for the same reason as above.

Summary

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reen DenTech Co., Ltd

2F. No. 17, Deyuanpi Blvd., Da Nong Li, Liouying District, Tainan City, 73659, Taiwan.

MAY 0 6 2014

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is prepared in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 on May 06, 2014.

The assigned 510(k) number is: K131468

1. APPLICANT's NAME AND ADDRESS

Applicant' Name:	Green DenTech Co., Ltd
Address:	2F, No. 17, Deyuanpi Blvd., Da Nong Li,
	Liouying District, Tainan City, 73659,
	Taiwan.
Telephone:	886-6-6230999
Fax:	886-6-6230789
Official contact:	Henry H.J. Shih
Date Prepared:	May 06, 2014

2. DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Denracle Dental Abutment
Common Name:	Dental implant abutment
Classification Regulations:	Endosseous dental implant abutmentClass II, 21 CFR 872.3630
Product Code:	NHA
Classification Panel:	Dental Products Panel
Reviewing Branch:	Dental Devices

3. LEGALLY MARKETED DEVICES TDS Abutment for Friadent Xive - K103339.

4. DEVICE DESCRIPTION

INTENDED USE OF THE DEVICE 5.

This device is compatible with the following implant system: OSSTEM GS Fixture System 0 4.0 mm, Ø 4.5 mm and Ø 5.0 mm.

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T Green DenTech Co., Ltd

2F, No. 17, Deyuanpi Blvd., Da Nong Li, Liouying District, Tainan City, 73659, Taiwan.

6. TECHNOLOGICAL CHARACTERISTICS

Denracle Dental Abutment for Osstem GS Implant has the following similarities to the predicate devices, TDS Abutment for Friadent Xive, which have been determined by FDA:

· Has the same intended use,
. Use the same operating principle,
. Incorporates the same basic design,
. Incorporates the same materials, and
Is produced using the same processes.

The basis for Green DenTech Co., Ltd. Belief that TDS Abutment for Friadent Xive is substantially equivalent to the predicate devices is summarized in the following table.

	Predicate Devices	Subject Device
	Denracle Dental Abutment for	Pou Yu Biotechnology Co.
	Osstem GS implant	TDS Abutment for Friadent XiveK103339
Intended use	Denracle Dental Abutment forOsstem GS Implant is intended foruse with dental implants as asupport for single or multiple toothprostheses in the maxilla ormandible of a partially or fullyedentulous patient.Denracle Dental Abutment forOsstem GS Implant is compatiblewith the following implant system:OSSTEM GS Fixture System Ø 4.0mm, Ø 4.5 mm and Ø 5.0 mm.	TDS Abutment for Friadent Xive isintended for use with dentalimplants as a support for single ormultiple tooth prostheses in themaxilla or mandible of a partially orfully edentulous patient.TDS Abutment for Friadent Xive iscompatible with the followingimplant systems which have aninternal hex 1.78mm or greater:Firadent: FRIALIT Implant, XiveImplant; 3i: Internal connect Type;Astra: Osseospeed Implant,Osseospeed TX Implant;BioHorizons: Internal Implantsystem, Tapered Internal ImplantSystem, Single-Stange ImplantSystem, Laser-lok 3.0 implantRENOVA ™ Internal Hex ImplantSystem; Zimmer: TaperedScrew-Vent Implant System,Screw-Vent Implant System,AdVent Implant System; Osstem:GS system; Noble Biocare: ActiveImpalnt.
Custom Design
Attachment	Implant level	Implant level
Restoration	Cement-retained	Cement-retained
CAD/CAMprocessing	Not CAD/CAM millable	Yes
Material
Abutment	Ti-6A1-4V ELI	Ti-6A1-4V ELIY-TZP Zinconia
Screw	Provided by Green Dentech Co.,Ltd.	Provided by Pou Yu BiotechnologyCo. Ltd

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reen DenTech Co., Ltd

2F, No. 17, Deyuanpi Blvd., Da Nong Li, Liouying District, Tainan City, 73659, Taiwan.

7. NON-CLINICAL TESTING DATA

Mechanical testing, according to ISO 14801 Dentistry - Fatigue test for endosseous dental implants, was conducted on a worst-case scenario to ensure that the strength Denral Abutment for Osstem GS Implant is appropriate for its intended use.

Compatibility testing was conducted on the abutments and corresponding dental implants (which have had previous 510(K) clearance in K072896) with designated screws, the dimensions, tolerances and rotation parameters were evaluated in determining appropriate fit.

Biocompatibility testing and sterilization was performed on the device with acceptable results.

These testing results show that Denracle Dental Abutment for Osstem GS Implant made of titanium, for their respective dental implant system have sufficient mechanical strength for their intended clinical application and are compatible with the implant system for which they are indicated for use.

8. CONCLUSION

Green DenTech Co., Ltd demonstrated that, for the purposes of FDA's regulation of medical devices, GO series Dental Abutment for Osstem GS Implant 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/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

Public Health Service

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

May 6, 2014

Green DenTech Company Limited Ms. Sue Ru Official Correspondent 2F, No. 17. Deyuanpi Boulevard Danung Li, Liouying District Tainan 73659 TAIWAN

Re: K131468

Trade/Device Name: Denracle Dental Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 13, 2014 Received: March 24, 2014

Dear Ms. Ru:

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. Ru

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 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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

MarySBunner-S

Erin I. Keith, M.S. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known) K131468

Device Name Denracle Dental abutment

Indications for Use (Describe)

manage Dental Abument for OSSTEM GS Implant is intended for use with dental implant as a support for single or multiple tooth prosthoses in maxilla or mandible of a partially or fully edentulous patient. This device is compatible with the following implant system:OSSTEM GS Fixture System 04.0mm > 04.5mm > 05.0mm •

Type of Use (Select one or both, as epplicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995. •DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of Information Is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chlef Information Officer Paparwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of Information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

PJC Tablinkang Sermans (J0 | ) 443-4740

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{6}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K131468

Device Name Denracle Dental abutment

Indications for Use (Describe)

morale Dental Abutunent for OSSTEM GS implant is intended for use with destablimplant as a support for single or multiple tooth prostheses in maxilla or mandible of a partially or fully edentulous patient. This device is compatible with the following implant system:OSSTEM GS Fixture System 64.0mm > ø4.5mm > ø5.0mm •

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)	Sheena A. Green -S
	2014.05.06 12:54:45
	-04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 78 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

Page 1 of 1

PIC Publica: Bertuu (201) 417-674)

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.)