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K Number
K974465
Device Name
SYNERGY
Manufacturer
COLTENE/WHALEDENT INC.
Date Cleared
1998-03-09

(103 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

SYNERGY Shades (enamel) A1/D2, A2/B2, A3/D3, A4/M5, A3.5/B3, C2/C3 is indicated for:

  • direct filling of class I, II, III, IV and V cavities
  • reconstruction of natural enamel and dentine
  • reconstruction of fractured anteriors
  • sealing of extended fissure in molars and premolars
  • stabilization of mobile anteriors
  • repair of veneer facings
  • fixation of splints
  • bonded bridges
  • esthetic

Synergy Compact (dentin) A2/B2, A3/D3, A3.5/B3 is specifically indicated for:

  • core reconstruction in highly esthetic class I, II, III restorations, which are subsequently covered with a more translucent material
  • direct class V fillings
  • direct filling of opaque teeth
  • palatinal of class IV restorations
  • core build-ups
  • shape and color corrections to improve esthetics

SYNERGY Transparent is specifically indicated for:

  • reconstruction of incisal edges in class IV fillings
  • translucent surface layers in all classes
  • covering characterizations

Super White is especially indicated for:

  • restoration of whitened teeth
  • restoration of deciduous teeth
  • characterization of chalk spots
  • veneering of anteriors
Device Description

SYNERGY Composite System.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the SYNERGY Composite System, a dental filling material. It states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has been determined to be as safe and effective as existing products.

However, this document does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or different types of performance studies (MRMC, standalone). These details are typically found in the applicant's 510(k) submission document, which is not included here.

Therefore,Based on the provided text, none of the requested information can be extracted. The document is an FDA clearance letter confirming substantial equivalence, but it does not detail the specific studies, acceptance criteria, or performance metrics used to reach that determination.

§ 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.