BIFIX QM

K060894 · Voco GmbH · EMA · May 2, 2006 · Dental

Device Facts

• Record ID: K060894
• Device Name: BIFIX QM
• Applicant: Voco GmbH
• Product Code: EMA · Dental
• Decision Date: May 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bifix QM is intended for adhesive luting of inlays, onlays, facettes, veneers, crowns, partial crowns, pins, posts, bridges and adhesive bridges (Maryland bridges).

Device Story

Bifix QM is a dental cement used by dental professionals for the adhesive luting of various indirect restorations, including inlays, onlays, veneers, crowns, and bridges. The device functions as a bonding agent to secure these restorations to tooth structure. It is applied in a clinical setting by a dentist or dental professional. The output is a secure, adhesive bond between the restoration and the tooth, which restores function and aesthetics for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental cement classified under 21 CFR 872.3275, Product Code EMA. The device is a chemical-based luting material used for permanent or temporary fixation of dental prosthetics.

Indications for Use

Indicated for adhesive luting of dental restorations including inlays, onlays, facettes, veneers, crowns, partial crowns, pins, posts, and bridges (including Maryland bridges).

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2006

Dr. Michael Süs Manager for Regulatory Affairs VOCO GmbH Anton-Flettner-Strasse 1-3 Cuxhaven, GERMANY D-27472

Re: K060894

Trade/Device Name: Bifix QM Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 31, 2006 Received: April 3, 2006

Dear Dr. Süs:

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 - Dr. Süs

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.

Sitte y. Mainau Ens.

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 Statement

510(k) Number: K060894

Device Name: Bifix QM

Indications for Use:

Bifix QM is intended for adhesive luting of inlays, onlays, facettes, veneers, crowns, partial crowns, pins, posts, bridges and adhesive bridges (Maryland bridges).

Prescription Use

OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kei Mulvey for MSR

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K060894

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