BIFIX SE

K083438 · Voco GmbH · EMA · Feb 13, 2009 · Dental

Device Facts

• Record ID: K083438
• Device Name: BIFIX SE
• Applicant: Voco GmbH
• Product Code: EMA · Dental
• Decision Date: Feb 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bifix SE is intended for the following applications: - permanent luting of inlays, onlays, crowns and bridges made from ceramic, composite and/or metal - permanent luting of metal, ceramic and fibre-reinforced posts

Device Story

Bifix SE is a dental cement used by dentists for permanent luting of indirect restorations (inlays, onlays, crowns, bridges) and posts. It functions as a bonding agent to secure prosthetic dental components to prepared tooth structures. The device is applied by the clinician in a dental office setting. It provides mechanical and chemical retention of the restoration, ensuring stability and long-term fixation. The output is the cured cement layer that bridges the interface between the tooth and the restoration, facilitating clinical success by preventing microleakage and restoration displacement.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental cement (Product Code: EMA). Classified under 21 CFR 872.3275. Material composition includes ceramic, composite, and metal-compatible components for luting applications.

Indications for Use

Indicated for permanent luting of inlays, onlays, crowns, bridges (ceramic, composite, metal), and metal, ceramic, or fibre-reinforced posts in dental patients.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. T. Gerkensmeier Regulatory Affairs VOCO GmbH Anton-Flettner-Strasse 1 - 3 27472 Cuxhaven GERMANY

FEB 1 3 2009

K083438 Re:

> Trade/Device Name: Bifix SE Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class; II Product Code: EMA Dated: November 17, 2008 Received: November 20, 2008

### Dear Dr. Gerkensmeir:

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. Gerkensmeire

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Ginette Y. Michaud, M.D. 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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# Indications for Us♠ Statement

K683438

510(k) Number:

Bifix SE Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Bifix SE is intended for the following applications:

- permanent luting of inlays, onlays, crowns and bridges made from ceramic, composite and/or metal
- permanent luting of metal, ceramic and fibre-reinforced posts

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)

Susan Runne
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083438