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K Number
K112168
Device Name
COMPONEER
Manufacturer
COLTENE/WHALEDENT AG
Date Cleared
2011-11-21

(116 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
  • -restoration therapy for caries
  • -optimisation of old restorations
  • -tooth fractures
  • -extending incisors
  • -malpositioned teeth
  • -tooth discoloration, incorrect shading
  • -anatomical malformation
  • -diasteme
  • -attrition, abrasion, erosion
  • -cosmetic correction
Device Description

COMPONEER are polymerised, radio-opaque composite shells

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA regarding a dental device called COMPONEER. It does not contain information about the acceptance criteria or a study proving the device meets said criteria for an AI/ML powered medical device.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination based on comparing the new device to existing ones, rather than through a study with specified acceptance criteria for algorithm performance.

Therefore, I cannot extract the requested information from this document.

§ 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.