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K Number
K070191
Device Name
ALPHA-CORE DC
Manufacturer
DENTAL TECHNOLOGIES, INC.
Date Cleared
2007-03-07

(44 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Core buildups. ■
  • . Cementation of pins and posts when used with suitable dentin adhesive.
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the "Alpha-Core DC" device, primarily focused on confirming its substantial equivalence to a predicate device for specific indications of use (core buildups and cementation of pins and posts).

The letter does not include:

  • A table of acceptance criteria or reported device performance metrics.
  • Details about a study's sample size, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
  • Information about multi-reader multi-case (MRMC) studies, effect sizes, or standalone algorithm performance.
  • Details on the sample size or ground truth establishment for a training set (which would be relevant for AI/ML devices, but this device is a dental material).

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

§ 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.