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K Number
K171200
Device Name
Grandio blocs
Manufacturer
VOCO GmbH
Date Cleared
2017-08-10

(108 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
  • Crowns, inlays, onlays, veneers
  • Implant supported crowns
Device Description

Not Found

AI/ML Overview

The provided documents do not contain information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for the Grandio blocs device.

The documents are a 510(k) clearance letter from the FDA for a dental resin material named "Grandio blocs." This letter primarily confirms that the device has been found substantially equivalent to predicate devices and outlines general regulatory requirements.

Specifically:

  • There is no mention of a study proving the device meets acceptance criteria.
  • No acceptance criteria or reported device performance are presented.
  • No sample sizes for test or training sets are provided.
  • No information on data provenance (country, retrospective/prospective) is given.
  • No details on experts or ground truth establishment are available.
  • No adjudication method is described.
  • No MRMC comparative effectiveness study is mentioned.
  • No standalone algorithm performance is discussed, as this device is a physical dental material, not an AI/software device.
  • No type of ground truth is specified.

§ 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.