FUTURABOND NR SINGLE DOSE

K053392 · Voco GmbH · KLE · Dec 15, 2005 · Dental

Device Facts

• Record ID: K053392
• Device Name: FUTURABOND NR SINGLE DOSE
• Applicant: Voco GmbH
• Product Code: KLE · Dental
• Decision Date: Dec 15, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Futurabond NR Single Dose is intended to be applied onto the interior of a prepared cavity for the bonding of a restoration.

Device Story

Futurabond NR Single Dose is a dental resin bonding agent. It is applied by a dental professional to the interior of a prepared tooth cavity to facilitate the adhesion of restorative materials. The device functions as an adhesive interface between the tooth structure and the restoration. It is supplied in a single-dose format for clinical use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resin tooth bonding agent (21 CFR 872.3200). Product code: KLE. Single-dose delivery system.

Indications for Use

Indicated for use as a dental bonding agent for the restoration of prepared cavities.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 15 2005

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

Re: K053392

Trade/Device Name: Futurabond NR Single Dose Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 29, 2005 Received: December 05, 2005

### Dear Dr. Sues:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) prematic is substantialy equivalent (for the indications for referenced above and have delemined the acceded increase markeed in interstate commerce
use stated in the enclosure) to legally market of next Americas that use stated in the enclosure) to legally mansics and the Medice Amendments, or to devices that prior to May 28, 1976, the enactment date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal From Nov. have been reclassified in accordance with the provisions application (PMA). You may,
Act (Act) that do not require approval of a premarket approval applications of the Act . Act (Act) that do not require approval or a prematiconspisions of the Act. The general
therefore, market the device, subject to the general controls provisions of the Act. therefore, market the device, subject to the general one of eegistration, listing of devices, good
controls provisions of the Act include requirements for and adulteration controls provisions of the Act metude requirements as an adulteration.
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 If your device is classified (see above) into Child Chass if (ersentials affecting your device can be
may be subject to such additional controls. Existing major regulations may be subject to such additions, Title 21, Parts 800 to 898 . In addition, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to 898 . In additio found in the Code of Federal Regarments your device in the Federal Register.

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### Page 2 - Dr. Michael Sues

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 that I Dr. I also muse a actregulations 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); an the 760 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) rmoviet notification. The FDA finding of substantial equivalence of your device to a legally premated no dicate 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" (21 CFR 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,

Ching-S. Liu, Ph.D.

Chiu S. Lin, PhD 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

## 510(k) Number (if known): __K053392

Device Name: Futurabond NR Single Dose Indications for Use:

Futurabond NR Single Dose is intended to be applied onto the interior of a prepared Futurabond NR Single Dood is internation of a restoration.

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)

Susan Viner

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