VINTAGE AL

K032165 · Shofu Dental Corp. · EIH · Sep 16, 2003 · Dental

Device Facts

• Record ID: K032165
• Device Name: VINTAGE AL
• Applicant: Shofu Dental Corp.
• Product Code: EIH · Dental
• Decision Date: Sep 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Vintage AL is dental porcelain used for fabricating crown restorations (all ceramic crown), built up on a ceramic substructure (aluminum oxide-based) and then fired.

Device Story

Vintage AL is a dental porcelain material used by dental professionals in a laboratory setting to fabricate all-ceramic crown restorations. The material is applied to an aluminum oxide-based ceramic substructure and subsequently fired to create the final dental restoration. The device serves as a restorative material for dental patients requiring crowns. It is a passive material; it does not involve electronic processing, software, or automated decision-making.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental porcelain powder for clinical use. Designed for application onto aluminum oxide-based ceramic substructures. Requires firing process for final restoration formation. Class II device per 21 CFR 872.6660.

Indications for Use

Indicated for fabrication of all-ceramic crown restorations built upon aluminum oxide-based ceramic substructures.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2003

Mr. Robert Noble President Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92069-4059

Re: K032165 Trade/Device Name: Vintage AL Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 10, 2003 Received: July 23, 2003

Dear Mr. Noble:

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. Noble

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 (OS) 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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Susan Gunner

Susan Runner, DDS, MA Interim 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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## K032165

Vintage AL Dental Ceramic

## Indication for Use

Vintage AL is dental porcelain used for fabricating crown restorations (all ceramic crown), built up on a ceramic substructure (aluminum oxide-based) and then fired.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use or

, '

Over –The-Counter Use

Ken Ruby in NSR

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

510(k) Number: K032165