VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98

K060441 · Vident · EIH · Apr 27, 2006 · Dental

Device Facts

• Record ID: K060441
• Device Name: VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98
• Applicant: Vident
• Product Code: EIH · Dental
• Decision Date: Apr 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown. For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.

Device Story

Vita VM® is a dental porcelain powder used by dental professionals to create veneers for fixed prostheses. The material is applied to metal or ceramic substructures to form the anatomical shape of a dental crown or bridge. The device functions as a restorative material in prosthetic dentistry to improve the aesthetic and functional properties of dental restorations. It is intended for professional clinical use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Porcelain powder for clinical use. Material is a ceramic-based veneering agent for application onto metal or ceramic substructures. Class II device under 21 CFR 872.6660.

Indications for Use

Indicated for use as a veneering material for fixed dental prostheses, including crowns, bridges, and dental implant abutments. For use by dental professionals (DDS/DMD) only; not for OTC use.

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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Barbara J. Lewandowski Regulatory Affairs Specialist VIDENT Incorporated 3150 East Birch Street Brea, California 92821

APR 2 7 2006

Re: K060441

Trade/Device Name: Vita VM® Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: February 16, 2006 Received: February 22, 2006

Dear Ms. Lewandowski:

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 IH (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 - Ms. Barbara J. Lewandowski

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" (21 CFR 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,

Chiu S. Lin, PhD

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

510(k) Number (if known):

Device Name: Vita VM® Indications for Use:

Ko 60441

Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.

For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.

Prescription Use × (21 CFR Part 801 Subpart D)

AND/OR

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

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)

Division of Dental, Infection Control and General Hospital Devices

510(k) Number

Prescription Use (Par. 21 CFR 801.109

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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