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K Number
K110642
Device Name
SILJETR SYSTEM
Manufacturer
DANVILLE MATERIALS INC.
Date Cleared
2011-05-27

(81 days)

Product Code
EBF,KLE,KOJ
Regulation Number
872.3690
Type
Traditional
Panel
Dental
Reference & Predicate Devices
K101402
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Silver system is a system used to The and repair cerainic and intettil oond Vestoration S dental

Device Description

SilJet System

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The document is primarily a letter from the FDA regarding a 510(k) premarket notification for the "SilJet System" device, indicating substantial equivalence to predicate devices. It discusses regulatory requirements but does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes, data provenance, or ground truth establishment for test or training sets.
  • Information on expert qualifications, adjudication methods, or MRMC studies.
  • Results from standalone algorithm performance tests.

The document states the "Indications for Use" for the SilJet System, which is "a system used to repair ceramic and indirectly bonded dental restorations." However, it does not provide the specific performance metrics or study details to support this indication.

§ 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.