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K Number
K102255
Device Name
DMP ETCHING GEL
Manufacturer
DMP LTD
Date Cleared
2010-11-23

(105 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • · Etching the enamel and dentin for adhesive restorations ·
Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer the request. The document is a 510(k) premarket notification letter for a dental etching gel (DMP Etching Gel). It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, details about AI assistance studies, standalone algorithm performance, or how ground truth was established. It focuses solely on the regulatory clearance process for a dental product.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.