MODIFICATION TO REBILDA DC

K060893 · Voco GmbH · EBF · May 25, 2006 · Dental

Device Facts

• Record ID: K060893
• Device Name: MODIFICATION TO REBILDA DC
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Rebilda DC is intended for core build-up of vital and non-vital teeth

Device Story

Rebilda DC is a dental material used for core build-up of vital and non-vital teeth. It is applied by dental professionals in a clinical setting to restore tooth structure. The material functions as a restorative resin, providing a foundation for subsequent crown or bridge placement. It supports clinical decision-making by enabling the reconstruction of damaged teeth, thereby preserving tooth function and structural integrity for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Tooth shade resin material; classified under 21 CFR 872.3690; product code EBF. Material properties consistent with standard dental core build-up resins.

Indications for Use

Indicated for core build-up of vital and non-vital teeth.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 25 3

Dr. Michael Sües Manager for Regulatory Affairs VOCO GmbH Anton-Flettner-Straße 1-3 27472 Cuxhaven, GERMANY

Re: K060893

Trade/Device Name: Rebilda DC Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: May 4, 2006 Received: May 8, 2006

Dear Dr Sües:

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. Sües

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 vour device to proceed to the market.

If vou 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 vours.

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

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## Indications for Use Statement

510(k) Number:

Device Name: Rebilda DC

Indications for Use:

Rebilda DC is intended for core build-up of vital and non-vital teeth

Prescription Use __X

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 Runge

Ancelliestology, General Hi n Connol, Dental Devi

K060893