FUTURABOND M+ by VOCO GMBH | FDA 510(k) Summary

[A1] Adhesive for direct restorations of all classes of cavities using light-curing . composite /compomer / OrmocerR materials with a methacrylate base.
[A2] Adhesive for core build-ups made of light-curing composite materials. .
[A3] Adhesive for indirect restorations with light-curing luting composites. .
[B] Intraoral repair of composite, compomer or OrmocerR restorations, ceramic veneers and allceramic restorations without an additional primer.
[C] Treatment of hypersensitive tooth necks. .
[D] Protective varnish for glass ionomer cement restorations. .
[E1] Sealing of cavities prior to amalgam restorations. .
[E2] Sealing of cavities and core preparations prior to the temporary luting of . indirect restorations. In combination with Futurabond M+ DCA (Dual Cure Activator):
[F1] Adhesive for direct self-curing or dual-curing composite restorations of all . classes of cavities and for core build-ups.
[F2] Adhesive for indirect restorations using dual-curing or self-curing luting . composites.
[G] Luting of root posts with dual-curing or self-curing luting composites. .
[H] Primer for surface preparation of adhesively luted indirect restoration materials . and root posts.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental bonding agent called "Futurabond M+". It does not contain any information about acceptance criteria or specific study data showing device performance.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was cleared based on substantial equivalence to existing devices, rather than through a new clinical effectiveness study demonstrating specific performance metrics against pre-defined acceptance criteria.

The document is purely an FDA clearance letter and an "Indications for Use Statement."

Summary

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

August 1, 2014

VOCO GmbH Dr. T. Gerkensmeier Regulatory Affairs Anton-Flettner-Str 1-3 27472 Cuxhaven Germany

Re: K141610

Trade/Device Name: Futurabond M+ Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: July 7, 2014 Received: July 7, 2014

Dear Dr. Gerkensmerer:

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. 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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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); medical device reporting (reporting of medical device-related 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, 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: _ K 141610

Device Name: _________________________________________________________________________________________________________________________________________________________________ Futurabond M+

Indications for Use:

Futurabond M+ is intended for use as:

[A1] Adhesive for direct restorations of all classes of cavities using light-curing . composite /compomer / OrmocerR materials with a methacrylate base.
[A2] Adhesive for core build-ups made of light-curing composite materials. .
[A3] Adhesive for indirect restorations with light-curing luting composites. .
[B] Intraoral repair of composite, compomer or OrmocerR restorations, ceramic veneers and allceramic restorations without an additional primer.
[C] Treatment of hypersensitive tooth necks. .
[D] Protective varnish for glass ionomer cement restorations. .
[E1] Sealing of cavities prior to amalgam restorations. .
[E2] Sealing of cavities and core preparations prior to the temporary luting of . indirect restorations. In combination with Futurabond M+ DCA (Dual Cure Activator):
[F1] Adhesive for direct self-curing or dual-curing composite restorations of all . classes of cavities and for core build-ups.
[F2] Adhesive for indirect restorations using dual-curing or self-curing luting . composites.
[G] Luting of root posts with dual-curing or self-curing luting composites. .
[H] Primer for surface preparation of adhesively luted indirect restoration materials . and root posts.

Prescription Use X

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)

Sheena A. Green -S 2014.08.01 11:50:42 -04'00'

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
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.(b)
Classification. Class II.