CEREC VITABLOCKS MK2

K022408 · B.B.'S Prophy Shop · EIH · Sep 6, 2002 · Dental

Device Facts

• Record ID: K022408
• Device Name: CEREC VITABLOCKS MK2
• Applicant: B.B.'S Prophy Shop
• Product Code: EIH · Dental
• Decision Date: Sep 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Production of ceramic inlays, onlays, veneers, crowns & bridges using the Cerec machine

Device Story

VITABLOCS Mark II are ceramic blocks used for the fabrication of dental restorations. The device is processed by the Cerec machine, a CAD/CAM system, to mill inlays, onlays, veneers, crowns, and bridges. Used in dental clinics by dentists or dental technicians. The output is a custom-fitted ceramic dental restoration. The device benefits patients by providing durable, aesthetic, and biocompatible tooth replacements.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ceramic material for dental restoration. Form factor: blocks for CAD/CAM milling. Intended for use with Cerec machine systems.

Indications for Use

Indicated for the production of ceramic inlays, onlays, veneers, crowns, and bridges using the Cerec machine in dental patients requiring restorative procedures.

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 6 2002

Dr. Horst Michael Birkhoff BB's Prophy Shop Grunstraße 2 41516 Grevenbroich-Wevelinghoven GERMANY

Re: K022408

Trade/Device Name: VITABLOCS® Mark II Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 24, 2002 Received: July 24, 2002

Dear Dr. Birkhoff:

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.

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.

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## Page 2 - Dr. Birkhoff

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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.

lottellutrshordn fer

Timothy A. Ulatowski 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

Page 1 of 6

510(k) Number (if known): K 022408

Device Name: VITABLOCKS

Indications for Use:

Production of ceramic inlays, onlays,
veneers, crowns & bridges using the
Cerec machine

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINGE ON ANOTHER PAGE IF NEEDED)

Prescription Use V (Per 21 CFR 801.109)

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Over-the-Counter Use

(Optional Format 1-2-96)

Course of the course of

Susan Ruane

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

510/k) Number