VITA VMK MASTER

K093446 · Vita Zahnfabrik H. Rauter GmbH & Co. Kg. · EIH · Dec 3, 2009 · Dental

Device Facts

• Record ID: K093446
• Device Name: VITA VMK MASTER
• Applicant: Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
• Product Code: EIH · Dental
• Decision Date: Dec 3, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Vita VMK Master® is indicated for use as part of a dental restoration in the form of a ceramic veneering material (full or partial) of a metal substructure. 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 VMK Master is a ceramic veneering material applied to metal substructures to create dental restorations. Used by dental professionals (DDS/DMD) in clinical or laboratory settings to restore tooth form and function. The material is layered onto metal frameworks to provide aesthetic and functional coverage. Benefits include restoration of dental anatomy and aesthetics for patients requiring prosthetic treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ceramic veneering material for metal substructures. Classified as porcelain powder for clinical use under 21 CFR 872.6660. Material properties consistent with standard dental ceramics used for metal-ceramic restorations.

Indications for Use

Indicated for use as a ceramic veneering material for full or partial dental restorations on metal substructures. 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with its wings spread, symbolizing protection and service. The seal is used to represent the HHS and its mission to enhance the health and well-being of Americans.

DEC - 3 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Vita Zahnfabrik H. Rauter GmbH & Company KG C/O Ms. Elizabeth Wolfsen Regulatory Affairs Specialist Vident 3150 East Birch Street Brea, California 92821

Re: K093446

Trade/Device Name: Vita VMK Master® Regulation Number: 21CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 4, 2009 Received: November 6, 2009

Dear Ms. Wolfsen:

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 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. Wolfsen

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

for

Susan Runner, D.D.S., M.A. Acting 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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K093446

## Indications for Use

510(k) Number (if known):

Device Name: Vita VMK Master® Indications for Use:

Vita VMK Master® is indicated for use as part of a dental restoration in the form of a ceramic veneering material (full or partial) of a metal substructure.

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)

R.Betz DOS for Dr. Kevin Muhling

vision 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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