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K Number
K182778
Device Name
LC GLOSSFILL XR
Manufacturer
S&C Polymer Silicon- und Composite Spezialitaeten GmbH
Date Cleared
2019-04-22

(203 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
K222445
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Anterior restorations (class III and IV)
  • Class V restorations
  • Posterior restorations (class I and II)
  • Reconstruction of damaged anterior teeth
  • Splinting of mobile teeth
  • Veneering of discoloured anterior teeth
  • Extended fissure sealing
  • . Repair of factes
  • Extraoral fabrication of inlays / onlays
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) clearance letter for the LC Glossfill XR device does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI/ML-based medical device.

The document is a standard FDA clearance letter for a dental material (Tooth Shade Resin Material). It discusses:

  • The device name (LC Glossfill XR)
  • Regulation number and name (21 CFR 872.3690, Tooth Shade Resin Material)
  • Regulatory class (Class II)
  • Product code (EBF)
  • Date of clearance
  • General controls provisions of the Act (registration, listing, GMP, labeling)
  • Contact information for FDA resources
  • Indications for Use (anterior/posterior restorations, class V, reconstruction, splinting, veneering, fissure sealing, repair, extraoral fabrication of inlays/onlays)

There is no mention of:

  • Any AI/ML component or software
  • Acceptance criteria for an AI/ML system
  • Device performance data or metrics (e.g., sensitivity, specificity, AUC)
  • Sample sizes for test or training sets
  • Ground truth establishment
  • Expert involvement or adjudication
  • MRMC studies
  • Standalone algorithm performance

Therefore, I cannot extract the requested information from this document. If you have a document related to an AI/ML medical device that includes such study details, please provide that.

§ 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.