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K Number
K102257
Device Name
NANOCERAM- BRIGHT
Manufacturer
DMP LTD
Date Cleared
2010-11-19

(101 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
  • Anterior restorations (Class III, IV)
  • Posterior restorations (Class I, II)
  • Class V restorations (Cervical caries, root erosion, wedge shaped defects)
  • Veneering of discolored anterior teeth
  • Splinting of mobile teeth . : .
  • Repair of composite and ceramic veneers
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental restorative material called NANOCERAM-BRIGHT. This document is related to regulatory clearance and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the input text. The document confirms the device's regulatory classification and lists its intended uses but does not include any technical study details.

§ 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.