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K Number
K102254
Device Name
DMP SINGLE BONDING
Manufacturer
DMP LTD
Date Cleared
2010-11-23

(105 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
  • · Bonding agent (bonding liquid) for adhesive restorations
  • · Transparent sealant for fissures and restorations
  • Bonding layer for the repair of resin-, crown-, or bridge works .
Device Description

Not Found

AI/ML Overview

This document is a letter from the FDA regarding a 510(k) premarket notification for a dental bonding agent, DMP Single Bonding. It does not contain information about the acceptance criteria or a study that proves the device meets specific performance metrics. Therefore, I cannot extract the requested information.

The letter focuses on the substantial equivalence determination for the device, stating that it can be marketed subject to general controls and regulations. It does not provide any technical performance data, study designs, or ground truth establishment details.

§ 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.