ZirAce™ abutments are indicated for use in partially edentulous patients requiring prosthetic devices and/or endosseous implants to restore chewing function. They are especially applicable to anterior or canine teeth where the typical titanium color may show through the gum. In addition to the Branemark (Nobel Biocare) implants, the ZirAce™ abutments hexagon connector fits the external hexagon of the following implants:

. 3i ,
Lifecore Biomedical , .
Sterngold Implamed. .

Device Description

ZirAce "" is a ccramic abutment composed of zirconium oxide stabilized with yttrium oxide, and containing niobium oxide to improve the properties and color. The zirconium oxide stabilized with yttrium oxide ceramic has been used for about 25 years as hip-implant and other prostheses and is capable of machining by modern CAD-C'AM methods. Various versions of this ceramic have been cleared for dental uses as inlays onlays and vencers by Dentronic in K971414 and for such materials and crowns and copings by Cynovad in K033227 and Medin Tech in K043472. The material is radio-opaque, for ready visualization.

AI/ML Overview

The provided text focuses on the 510(k) summary for a dental implant abutment, Zir Ace™. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically understood in the context of clinical performance or algorithm evaluation.

The "studies" mentioned are primarily physical tests comparing the Zir Ace™ material to predicate devices and recognized standards (like ISO 14801 for "Dynamic Continuous Fatigue Test") to demonstrate material equivalence and biocompatibility.

Therefore, for almost all points in your request, the information is not present in the provided text. I will indicate where information is missing.

Acceptance Criteria and Device Performance Study for K051501 (Zir Ace™ Dental Abutment)

Based on the provided 510(k) summary, detailed acceptance criteria and a study demonstrating the device's performance against clinical or diagnostic metrics (as would be typical for an AI/algorithm-based device) are not presented. The submission focuses on substantial equivalence to predicate devices primarily through material and mechanical property comparisons.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Mechanical Properties	Equivalence in compressive strength to predicate materials (unspecified quantitative criteria).	Thoroughly tested with physical tests. Found equivalent to common yttrium stabilized zirconia.
	Equivalence in fracture toughness to predicate materials (unspecified quantitative criteria).	Thoroughly tested with physical tests. Found equivalent to common yttrium stabilized zirconia.
	Durability in accordance with ISO 14801 "Dynamic Continuous Fatigue Test" (unspecified quantitative criteria).	Tested in accordance with ISO 14801.
Biocompatibility	Equivalence in biocompatibility to common tetragonal yttrium stabilized zirconia.	Studied carefully; found equivalent to the common tetragonal yttrium stabilized zirconia.
Material Composition	Consistency with yttrium stabilized zirconium oxide with niobium oxide for color and properties.	Composed of zirconium oxide stabilized with yttrium oxide, containing niobium oxide.
Radiopacity	Ready visualization (unspecified quantitative criteria).	Material is radio-opaque, for ready visualization.
Intended Use	To be cemented or screw-fastened to endosseous dental implants to provide a basis for building a prostheses to provide mastication in edentulous or partly edentulous persons.	Same intended use as predicate devices. Meets this descriptive criterion.

Missing Information:

Specific numerical acceptance thresholds for mechanical properties (e.g., minimum compressive strength in MPa, number of cycles for fatigue).
Quantitative results from the physical tests for direct comparison.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided in the 510(k) summary. The "tests" referred to are physical, material-based tests, not clinical performance studies with patient or image data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable and not provided. The ground truth for material properties would be established by laboratory testing methodologies and standards, not expert consensus in a clinical diagnostic sense.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies, not for material property testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned as this submission is for a physical medical device (dental abutment), not an AI/algorithm-based diagnostic or assistive system. Therefore, there is no mention of human readers, AI assistance, or effect sizes.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done:

No. This is not an algorithm-based device, so a standalone performance study is not applicable.

7. The Type of Ground Truth Used:

The ground truth used for this submission is based on material science standards and laboratory measurements. This includes:

Physical properties (compressive strength, fracture toughness, durability) tested according to established methods (e.g., ISO 14801).
Biocompatibility evaluation against recognized standards for yttrium stabilized zirconia.
Chemical composition analysis.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. There is no "training set" as this is not an algorithm or AI-based device.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable and not provided, as there is no training set mentioned in the context of an algorithm. For the material properties, the "ground truth" (i.e., the expected performance or characteristics) is established by existing material standards, previously cleared predicate devices, and scientific literature.

Summary

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K051501

510(k) SUMMARY

OCT 1 & ZUUS

Kyung-Bin Lec, Pres., Acuccra, Inc., Namyangiu-si, Gyeonggi 472-861, (Seoul) Korea. Submitter: Phone: 82-(0)31-527-6940.

I. Classification Names and numbers: Endosscous dental implant abutment, code NHA,.

II. Common/Usual Name: Abutment, implant abutment

III. Proprietary Names: Zir Ace™

IV. Establishment Registration Number: Foreign, in process

V. Classification: These products have recently been classified by the Dental Products Panel into 21 CFR 872.3630, Class II.

VI. Device Description: ZirAce "" is a ccramic abutment composed of zirconium oxide stabilized with yttrium oxide, and containing niobium oxide to improve the properties and color. The zirconium oxide stabilized with yttrium oxide ceramic has been used for about 25 years as hip-implant and other prostheses and is capable of machining by modern CAD-C'AM methods. Various versions of this ceramic have been cleared for dental uses as inlays onlays and vencers by Dentronic in K971414 and for such materials and crowns and copings by Cynovad in K033227 and Medin Tech in K043472. The material is radio-opaque, for ready visualization.

VII. Substantial Equivalence: Zir Ace" is substantially equivalent, and nearly identical, to the Procera Abutment Branemark, cleared in K042658. It is equivalent to several other ceramic abutments, such as the Esthetic Zirconia Abutment (K031719), the Astra Tech Dental Implants-Ceramic abutment (K023631) and others such as the Ceramic Abutment (K9132255), the Procera Abutment System (K974150), the 3i Dental Abutment (K032263), and the Sterngold Implant (K081516). The material from which the Zir Ace" abutment is manufactured is couvalent to the common yttrium stabilized zircoma used in Denzir cleared by Dentronic AB in K984201 and Cynovad Zircon (K02327). This has been demonstrated by extensive physical tests summarized in Appendix IV and provided from the literature in Appendix V.

The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

These products have the same intended_use, to be cemented or screw-fastened to endosseous dental implants to provide a basis for building a prostheses to provide mastication in edentulous or partly edentulous persons.

(repl. p. 11)

XI.

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1. The technological characteristics for this product are similar to those for the predicate devices and those currently on the market except for slight differences in composition. Physical properties, including compressive strength, fracture toughness, and durability have been thoroughly tested with physical tests and in accordance with ISO 14801 "Dynamic Continuous Fatigue Test." The biocompatibility of the material used has also been studied carefully; it has been found equivalent to the common tetragonal yttrium stabilized zirconia.
1. Descriptive information provided shows that the materials from which this device is made are well established in the more demanding areas of hip implants and that they have been more well recognized for their broad use in dental structures.
1. The FDA "Decision-Making Process" chart was used and appears in Appendix V.1.

(End of Summary)

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2005

Mr. Kyung-Bin Lee President Acucera, Incorporated Namyangju-si, Gyeonggi Seoul REPUBLIC OF KOREA 472-861

Re: K051501

Trade/Device Name: ABUTMENT, IMPLANT ABUTMENT Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: September 30, 2005 Received: October 3, 2005

Dear Mr. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 mendments, 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 the Fought I beat, I beg, " Jou may, therefore, market the device, subject to the general approvisions 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 writ), it hay of 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. Lec

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); good manufacturing practice and insime (s 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), r you don't the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutte Y. Michael Om.D

Chiu Lin, Ph.D. 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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VIII.1 Indications for Use: [Separate Page]

510(k) Number: K051501

Device Name: Zir Acc"™ ccramic abutmcnt

Indications for use:

7.irAce™ abutments are indicated for use in partially edentulous patients requiring prosthetic devices and/or endosseous implants to restore chewing function. They are especially applicable to anterior or canine teeth where the typical titanium color may show through the gum. In addition to the Branemark (Nobel Biocare) implants, the ZirAce™ abutments hexagon connector fits the external hexagon of the following implants:

. 3i ,
Lifecore Biomedical , .
Sterngold Implamed. .

Preseription Use X (Per 21 CFR 801 Subpart D) ()[ર

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

PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Sura Ruser

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

510(k) Number:__

Repl. p. 5

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.)