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K Number
K073047
Device Name
APROXI 1100 AND 4000 SERIES DENTAL INLAYS
Manufacturer
APROXI APS
Date Cleared
2008-08-07

(283 days)

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

Inlays for Class II fillings

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding dental inlays. It discusses the substantial equivalence of the Aproxi 1100 and 4000 Series Dental Inlays to legally marketed predicate devices.

The letter does not contain any information about:

  • Acceptance criteria for a device's performance.
  • A study proving the device meets acceptance criteria.
  • Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I cannot fulfill your request based on the provided text.

§ 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.