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K Number
K121915
Device Name
BRIGHT RESTORATIVE MATERIALS
Manufacturer
DMP LTD
Date Cleared
2012-09-28

(88 days)

Product Code
EBF,EBC
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

BRIGHT Restorative Materials, to include:

  • NANOCERAM BRIGHT FLOW .
  • BRIGHT FLOW CORE .
  • BRIGHT HEAVY CORE .
  • BRIGHT LIGHT .
  • BRIGHT LIGHT FLOW .
  • · BRIGHT POSTERIOR

Indications for Use:

NANOCERAM - BRIGHT FLOW
Indications for use:

  • · Fillings of minimally invasive cavities of all classes
  • Fillings of small class I cavities .
  • Fillings of class II-V cavities including V-shaped defects and cervical caries
  • Extended fissure sealing
  • Cavity lining as the first layer for Class I and II restorations
  • Splinting of mobile teeth ●
  • Blocking out of undercuts
  • Small restorations of all types
  • Repair of composite restorations and ceramic veneers

BRIGHT FLOW CORE - BRIGHT HEAVY CORE
Indications for use:

  • Core build up of vital and non-vital teeth .
  • Post cementation

BRIGHT LIGHT - BRIGHT LIGHT FLOW
BRIGHT LIGHT
Indications for use:

  • Class I-V restorations .
  • Reconstruction of affected anterior teeth ●
  • Veneering of discoloured anterior teeth .
  • Splinting of mobile teeth
  • Repair of composite and ceramic veneers

BRIGHT LIGHT FLOW
Indications for use:

  • · Fillings of minimally invasive cavities of all classes
  • Fillings of class II-V cavities including V-shaped defects and cervical caries .
  • Extended fissure sealing .
  • Splinting of mobile teeth .
  • Blocking out of undercuts .
  • Small restorations of all types .
  • Repair of composite restorations and ceramic veneers

BRIGHT POSTERIOR
Indications for use:

  • · Direct posterior restorations (Class I and II), including occlusal surfaces
  • Core build ups ●
  • Splinting of mobile teeth
Device Description

Not Found

AI/ML Overview

The provided documentdoes not contain information about acceptance criteria or a study proving device performance against such criteria.

The document is a 510(k) premarket notification letter from the FDA to DMP. Limited regarding their "Bright Restorative Materials". It states that the device has been determined to be substantially equivalent to legally marketed predicate devices.

The content primarily focuses on:

  • The FDA's determination of substantial equivalence.
  • Regulatory information and obligations for the manufacturer.
  • Indications for use for various Bright Restorative Materials.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, ground truth details, or information about MRMC studies.

§ 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.