FUTURABOND DC/SINGLE DOSE

K070723 · Voco GmbH · KLE · Jun 7, 2007 · Dental

Device Facts

• Record ID: K070723
• Device Name: FUTURABOND DC/SINGLE DOSE
• Applicant: Voco GmbH
• Product Code: KLE · Dental
• Decision Date: Jun 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Futurabond DC/Single Dose is intended for direct self- or dual curing composite restaurations and core build-ups, direct light-curing composite/compomer/ormocer-based restaurations, fixing root pins/posts with dual- or self-curing composite cements, indirect restaurations with the application of dual-curing composite cements for bonding inlays, onlays, crowns and bridges.

Device Story

Futurabond DC/Single Dose is a dental resin bonding agent; used by dentists for direct and indirect restorative procedures. Device facilitates adhesion between tooth structure and restorative materials (composites, compomers, ormocers, cements). Applied by clinician to prepared tooth surface; functions as chemical bonding interface for direct restorations, core build-ups, and cementation of pins, posts, inlays, onlays, crowns, and bridges. Enables secure attachment of restorative materials to tooth structure; improves clinical outcomes by ensuring retention and marginal integrity of dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resin-based dental bonding agent; dual-curing (light-cure and self-cure) chemistry. Formulated for use with composite, compomer, and ormocer restorative materials. Supplied in single-dose delivery system.

Indications for Use

Indicated for dental patients requiring direct composite restorations, core build-ups, light-curing composite/compomer/ormocer restorations, cementation of root pins/posts, and bonding of indirect restorations (inlays, onlays, crowns, bridges) using dual-curing composite cements.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Thorsten Gerkensmeier Regulatory Affairs VOCO GmbH Anton-Flettner-Strasse 1-3 Cuxhaven, Germany 27472

JUN - 7 2007

Re: K070723

Trade/Device Name: Futurabond DC/Single Dose Regulation Number: 872.3200 Regulation Name: Resin Teeth Bonding Agent Regulatory Class: II Product Code: KLE Dated: March 13, 2007 Received: March 15, 2007

Dear Dr. Gerkensmeier:

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. Gerkensmeier

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 (OS) 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,

Sybil Y. Michael MD

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: K070723

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Futurabond DC/Single Dose is intended for direct self- or dual curing composite restaurations and core build-ups, direct light-curing composite/compomer/ormocer-based restaurations, fixing root pins/posts with dual- or self-curing composite cements, indirect restaurations with the application of dual-curing composite cements for bonding inlays, onlays, crowns and bridges.

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)

Susa Runser

Sign-Off)
ision of Anesthesiology, General Hospital

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

K01013