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K Number
K112447
Device Name
GRANDIO CORE DUAL CURE
Manufacturer
VOCO GMBH
Date Cleared
2011-11-08

(75 days)

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

Grandio Core Dual Cure:

  • core build ups of vital and non-vital teeth
  • Luting of root posts
Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a dental device called "Grandio Core Dual Cure." This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, clinical study design, or performance metrics.

Therefore, I cannot extract the requested information regarding:

  • Acceptance Criteria and Reported Device Performance: This information is not present.
  • Sample size used for the test set and data provenance: No test set or study data is described.
  • Number of experts used to establish the ground truth for the test set and qualifications: No ground truth establishment is described.
  • Adjudication method for the test set: Not applicable as no test set is described.
  • Multi reader multi case (MRMC) comparative effectiveness study: No such study is mentioned.
  • Standalone (algorithm only without human-in-the-loop performance): This is a dental material, not an AI algorithm.
  • Type of ground truth used: Not applicable as no study is described.
  • Sample size for the training set: Not applicable as no training set for an AI algorithm is involved.
  • How the ground truth for the training set was established: Not applicable.

The document discusses the regulatory review of a dental material's "substantial equivalence" to legally marketed predicate devices, based on its indications for use. It's a regulatory clearance, not a scientific study report.

§ 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.