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K Number
K062713
Device Name
ADHESIVE DC ACTIVATOR
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2006-11-02

(52 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Adhesive cementation of indirect meal-free restorations (inlays, onlays, crowns, bridges or of metal free posts with dual or self curing composites.

Direct restorations and core build-ups with dual and self curing composites.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental bonding agent, AdheSE® DC Activator, indicating it has been deemed substantially equivalent to a legally marketed predicate device.

It primarily details:

  • The device name and regulation number.
  • The date of clearance.
  • The regulatory classification (Class II).
  • General information about FDA regulations and compliance.
  • The intended indications for use of the device.

There is no mention of specific acceptance criteria, performance metrics, a study design, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

§ 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.