← Product Code [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE) · K070723 # FUTURABOND DC/SINGLE DOSE (K070723) _Voco GmbH · KLE · Jun 7, 2007 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K070723 ## Device Facts - **Applicant:** Voco GmbH - **Product Code:** [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE.md) - **Decision Date:** Jun 7, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3200 - **Device Class:** Class 2 - **Review Panel:** Dental ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, clutching what appears to be a caduceus, a symbol often associated with medicine and healthcare. 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. {1}------------------------------------------------ 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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 {2}------------------------------------------------ ## 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K070723](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K070723) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com