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K Number
K012322
Device Name
OPTIBOND 2
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
2001-08-30

(38 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

OptiBond 2 is a multi-purpose bonding agent designed to be used in direct situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, bonding composite core build-up materials, cavity liner, pulp capper, pit and fissure sealant, and indirect situations, i.e., onlays, inlays and crowns.

Device Description

OptiBond 2 is a multi-purpose bonding agent designed to be used in direct situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, bonding composite core build-up materials, cavity liner, pulp capper, pit and fissure sealant, and indirect situations, i.e., onlays, inlays and crowns.

AI/ML Overview

This document (K012322) is a 510(k) premarket notification for a dental bonding agent named OptiBond 2. It does not contain any information regarding acceptance criteria, performance studies, or clinical trial data. Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

The document primarily focuses on:

  • Device Name: OptiBond 2
  • Common Name: Pit and Fissure Sealant
  • Classification Name: Pit and Fissure Sealant and Conditioner
  • Substantial Equivalence: Claimed to be substantially equivalent to Kerr Corporation's Guardian Seal.
  • Device Description: A multi-purpose bonding agent for various direct and indirect dental applications.
  • Intended Use: Details the specific dental procedures where OptiBond 2 is intended to be used.
  • FDA Clearance: A letter from the FDA stating that the device has been reviewed and can be marketed based on its substantial equivalence to legally marketed predicate devices.

The document is purely administrative and regulatory in nature, indicating FDA clearance, but it does not include the technical or clinical data that would typically define and demonstrate meeting acceptance criteria.

§ 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.