STARCERAM

K081263 · H.C. Starck Ceramics GmbH & Co.Kg · EIH · Jul 1, 2008 · Dental

Device Facts

• Record ID: K081263
• Device Name: STARCERAM
• Applicant: H.C. Starck Ceramics GmbH & Co.Kg
• Product Code: EIH · Dental
• Decision Date: Jul 1, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

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.

Device Story

StarCeram consists of yttrium-stabilized, presintered zirconium dioxide dental blanks. These semifinished materials are processed by dental professionals using commercial CAD/CAM systems or hand-operated copy-milling machines to fabricate dental restorations, specifically crowns, multi-unit bridges, and inlay bridges. The device provides high biocompatibility and resistance to tension and pressure. The final restorations are used by clinicians to restore patient dentition. No clinical data was collected; safety and efficacy are supported by non-clinical bench testing and adherence to established dental material standards.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing validating design requirements against ANSI/ADA Specifications No. 69:1999 and ISO 6872:1995 + Amendment 1-1997.

Technological Characteristics

Material: Yttrium-stabilized, presintered zirconium dioxide. Form factor: Dental blanks (semifinished). Standards: ANSI/ADA Specifications No. 69:1999, ISO 6872:1995 + Amendment 1-1997. Risk management: ISO 14971. No software or electronic components.

Indications for Use

Indicated for patients requiring crowns, multi-unit bridges, or inlay bridges, including anterior and posterior applications.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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: [phone] / Fax: [phone]

#### 510(k) Correspondent

Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors 13605 West 7th Ave., Golden, CO USA Tel: [phone] / Fax: [phone]

#### 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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## Device Description and Intended Use

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.

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 [phone]. 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 [phone] or [phone] 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

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StarCeram 510(k) Page 14 of 113