VINTAGE ART

K080834 · Shofu Dental Corp. · EIH · Jun 11, 2008 · Dental

Device Facts

• Record ID: K080834
• Device Name: VINTAGE ART
• Applicant: Shofu Dental Corp.
• Product Code: EIH · Dental
• Decision Date: Jun 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Vintage Art is dental ceramic stain and is used for adjusting the shade of dental ceramic restorations or prostheses. It can reproduce natural-teeth like crown restorations and prostheses when built up on dental metal ceramic porcelain, dental porcelain, dental ceramic core material and porcelain teeth.

Device Story

Vintage Art is a dental ceramic stain used by dental professionals in a laboratory or clinical setting to adjust the shade of dental restorations. The material is applied to dental metal ceramic porcelain, dental porcelain, ceramic core materials, or porcelain teeth to mimic the appearance of natural teeth. It functions as a coloring agent for aesthetic customization of prostheses. The device is applied by dental technicians or clinicians during the fabrication or adjustment of crowns and bridges. It does not involve electronic processing, software, or automated analysis.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Dental ceramic stain material. Formulated for application to dental porcelain, metal ceramic porcelain, and ceramic core materials. Class II device (Product Code: EIH).

Indications for Use

Indicated for adjusting the shade of dental ceramic restorations or prostheses, including metal ceramic porcelain, dental porcelain, ceramic core materials, and porcelain teeth, to reproduce natural tooth appearance.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 11 2008

Mr. David P. Morais Operations Manager and Official Correspondent Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92078-4059

Re: K080834 Trade/Device Name: Vintage Art Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: March 24, 2008 Received: March 25, 2008

Dear Mr. Morais:

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. Morais

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,

Suette H. Michael Quid

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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## Indications for Use

K080834

510(k) Number (if known):

Device Name: Vintage Art

Indications For Use:

Vintage Art is dental ceramic stain and is used for adjusting the shade of dental ceramic restorations or prostheses. It can reproduce natural-teeth like crown restorations and prostheses when built up on dental metal ceramic porcelain, dental porcelain, dental ceramic core material and porcelain teeth.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muckey for MSR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Shofu Dental Corporation infection Control, Dental Devices VINTAGE ART 510(k) Premarket Notification

510(k) Number: