Dental Blanks made from StarCeram® Z-Med or StarCeram® Z-Al-Med HD are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.

Device Description

Dental blanks made of StarCeram® Z-Med or StarCeram® Z-AI-Med HD are dental materials (semifinished products) made of yttrium stabilized, presintered zirconium dioxide for milled production of crowns and bridge frameworks on commercial CAD/CAM systems or handoperated copy-milling machines, with outstanding biocompatibility and high resistance against tension and pressure.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the StarCeram device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., tensile strength greater than X, flexural strength greater than Y). Instead, it states that non-clinical testing was performed to validate the design against the company's specified design requirements and to assure conformance with two voluntary design standards.

Therefore, the "acceptance criteria" can be inferred as conformance to these standards and the company's internal design requirements.

Acceptance Criteria (Implied)	Reported Device Performance
Conformance with ANSI/ADA Specifications No. 69:1999	Non-clinical testing performed to assure conformance.
Conformance with ISO 6872:1995 + Amendment 1-1997	Non-clinical testing performed to assure conformance.
Validation against company's specified design requirements	Non-clinical testing performed to validate the design.
Demonstrated "outstanding biocompatibility"	Stated in device description as a characteristic.
Demonstrated "high resistance against tension and pressure"	Stated in device description as a characteristic.

2. Sample Size and Data Provenance for Test Set

Sample Size: The document does not specify the sample size used for the non-clinical testing.
Data Provenance: The document states that H.C. Starck Ceramics GmbH & Co. KG performed non-clinical testing. This suggests the data was generated internally by the manufacturer. The company is based in Selb, GERMANY, so the data provenance is likely Germany (retrospective, as it was generated before submission).

3. Number of Experts and Qualifications for Ground Truth, Test Set

This information is not applicable as the device is a material (porcelain powder) and the testing referenced is non-clinical (material property testing) rather than clinical or image-based diagnostic testing requiring expert human interpretation or ground truth establishment in a medical context.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

A MRMC comparative effectiveness study was not done. The submission explicitly states: "H.C. Starck Ceramics GmbH & Co. KG did not conduct, nor rely upon, clinical tests to determine substantial equivalence." This is a non-clinical device, not an AI or diagnostic device that would typically involve human reader studies.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done. This type of study is relevant for AI algorithms or diagnostic devices. The StarCeram is a dental material, and its evaluation focuses on material properties through non-clinical testing.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

Voluntary Design Standards: ANSI/ADA Specifications No. 69:1999 and ISO 6872:1995 + Amendment 1-1997.
Company's Specified Design Requirements: Internal specifications for material properties and performance.

8. Sample Size for the Training Set

This information is not applicable. This device is a material, not an AI system that requires a "training set."

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

This information is not applicable for the same reasons as point 8.

Summary

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510(k) Number:

Date: ________________________________________________________________________________________________________________________________________________________________________

Page 1 of 2

510(k) Summary

JUL -1 2008

2081263

Introduction

This summary is intended to comply with requirements of the SMDA and 21CFR§807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.

510(k) Applicant

H.C. Starck Ceramics GmbH & Co. KG Lorenz-Hutschenreuther-Str. 81 95100 Selb, GERMANY Tel: +49 92 878 07-0 / Fax: 92 878 07-477

510(k) Correspondent

Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors 13605 West 7th Ave., Golden, CO USA Tel: 303-463-0900 / Fax: 303-558-3833

Date Prepared

April 28, 2008

Trade Name of Device

StarCeram

Common Name of Device

Powder, Porcelain

Classification Name

Porcelain powder for clinical use

510(k) Classification

Class II

Predicate Devices

K051462 DENTSPLY International Cercon Base K062695 Sagemax Bioceramics, Inc. Sagemax Z-Blank K072569 Metoxit CAM Blanks

StarCeram 510(k) Page 16 of 113

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510(k) Number:
Date:

Page 2 of 2

Device Description and Intended Use

Dental Blanks made from StarCeram® Z-Med or StarCeram® Z-Al-Med HD are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.

Clinical and Non-Clinical Testing

II.C. Starck Ceramics GmbH & Co. KG did not conduct, nor rely upon, clinical tests to determinc substantial equivalence. Non-clinical testing was performed in order to validate the design against the company's specified design requirements, and to assure conformance with the following voluntary design standards:

ANSI ADA Specifications No. 69:1999

ISO 6872:1995 + Amendment 1-1997

Risk Management

This device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program according to ISO 14971 "Medical devices -Application of risk management to medical devices"

Substantial Equivalence

H.C. Starck Ceramics GmbH & Co. KG believes that StarCeram is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

JUL - 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

H.C. Starck Ceramics GmbH & Co. KG C/O Mr. Robert N. Clark President and Senior Consultant Medical Device Regulatory Advisors, Incorporated 13605 West 7th Avenue Golden, Colorado 80401-4604

Re: K081263

Trade/Device Name: StarCeram® Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: April 28, 2008 Received: May 5, 2008

Dear Mr. Clark:

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.

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 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. Clark

Enclosure

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 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.

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), please contact 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,

Chin-Lin, Ph.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

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Indications for Use

1208 1263 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: StarCeram _______________________________________________________________________________________________________________________________________________________

Indications for Use:

Dental Blanks made from StarCeram® Z-Med or StarCeram® Z-Al-Med HD are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kei Mulvey for MSR

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

510(k) Number: K081263

Page 1 of 1

StarCeram 510(k) Page 14 of 113

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.