VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9,

K052710 · Vident · EIH · Jan 13, 2006 · Dental

Device Facts

• Record ID: K052710
• Device Name: VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9,
• Applicant: Vident
• Product Code: EIH · Dental
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Special
• 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, including crowns, bridges, and dental implant abutments. The material is applied to ceramic or metal substructures to form the final dental crown shape. It is intended for clinical use in prosthetic dentistry to restore dental function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Porcelain powder for dental veneering. Class II device (21 CFR 872.6660).

Indications for Use

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

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2006

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

Re: K052710

Trade/Device Name: Vita VM® Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 10, 2006 Received: January 11, 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 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.

{1}------------------------------------------------

Page 2 – Ms. Lewandowski

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has madc a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or me ret 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), nlease 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,

Olaes

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: Vita VM® Indications for 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.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Quaner K032710

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

Page 1 of 1