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K Number
K141610
Device Name
FUTURABOND M+
Manufacturer
VOCO GMBH
Date Cleared
2014-08-01

(46 days)

Product Code
KLE
Regulation Number
872.3200
Type
Special
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.
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."

§ 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.