FUTURABOND UNIVERSAL

K130486 · Voco GmbH · KLE · Jun 20, 2013 · Dental

Device Facts

• Record ID: K130486
• Device Name: FUTURABOND UNIVERSAL
• Applicant: Voco GmbH
• Product Code: KLE · Dental
• Decision Date: Jun 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Futurabond Universal is intended for use as: - Adhesive for direct restorations of all classes of cavities using light-curing composite/compomer/Ormocer materials with a methacrylate base - Adhesive for core build-ups made of light-curing composite materials - Adhesive for indirect restorations with light-curing luting composites . - Intracral repair of composite, compomer or Ormocer restorations, ceramic veneers and all ceramic restorations without an additional primer - Treatment of hypersensitive tooth necks - Protective vamish for glass ionomer cement restorations - Sealing of cavities prior to amalgam restorations - Sealing of cavities and core preparations prior to the temporary luting of indirect restorations - Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups - Adhesive for indirect restorations using dual-curing or self-curing luting composites - Luting of root posts with dual-curing or self-curing luting composites

Device Story

Futurabond Universal is a dental adhesive system; used by dentists in clinical settings. Functions as a bonding agent for direct/indirect restorations, core build-ups, and cavity sealing. Applied to tooth structure to facilitate adhesion of composite, compomer, Ormocer, or glass ionomer materials. Enables repair of existing restorations and treatment of hypersensitive tooth necks. Provides chemical bond between tooth structure and restorative materials; supports light-curing, dual-curing, and self-curing protocols. Enhances clinical outcomes by improving retention and marginal integrity of dental restorations.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing.

Technological Characteristics

Resin-based dental adhesive; methacrylate-based chemistry. Compatible with light-curing, dual-curing, and self-curing restorative materials. Formulated for universal application across various cavity classes and restorative types. No specific ASTM standards or software components described.

Indications for Use

Indicated for dental patients requiring adhesive bonding for direct/indirect restorations, core build-ups, cavity sealing, repair of existing restorations, and treatment of hypersensitive tooth necks.

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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

### June 20, 2013

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

Re: K130486

Trade/Device Name: Futurabond U Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE, EMA Dated: April 16, 2013 Received: April 24, 2013

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 vour 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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ﻠ [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Runner DDS, MA Mary S.
Runner--S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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: _______________________________________________________________________________________________________________________________________________________________

#### Futurabond Universal Device Name:

Indications for Use:

-

ないです。このことを経営すると、ここではな

Futurabond Universal is intended for use as:

- Adhesive for direct restorations of all classes of cavities using light-curing composite/compomer/Ormocer materials with a methacrylate base
- Adhesive for core build-ups made of light-curing composite materials
- Adhesive for indirect restorations with light-curing luting composites .
- Intracral repair of composite, compomer or Ormocer restorations, ceramic veneers and all ceramic restorations without an additional primer
- Treatment of hypersensitive tooth necks
- Protective vamish for glass ionomer cement restorations
- Sealing of cavities prior to amalgam restorations
- Sealing of cavities and core preparations prior to the temporary luting of indirect restorations
- Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups
- Adhesive for indirect restorations using dual-curing or self-curing luting composites
- Luting of root posts with dual-curing or self-curing luting composites

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)

Andrew I. Steen 2013.06.20 08:46:34 04'00'

(Division Sign-Off) (Division of Anesthesloiogy, General Hospital Infection Control, Dental Devices

510(k) Number: K130486