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K Number
K033117
Device Name
GRANDIO FLOW
Manufacturer
VOCO GMBH
Date Cleared
2003-11-25

(56 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
  • Fillings of any minimally invasive cavity
  • Fillings of small cavities and extended fissure sealing
  • Block out undercuts
  • Lining or coating cavities
  • Class III-V fillings, including V-shaped defects and cervical caries
  • Repair of fillings and veneers
  • Luting of translucent prosthetic pieces, e.g., porcelain-only crowns
Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, I cannot provide a detailed answer to your request. The document is an FDA 510(k) clearance letter for a dental resin material named "Grandio® Flow." While it lists the indications for use of the device, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details related to AI or comparative effectiveness studies.

The document is a regulatory approval notice, not a technical report on device performance or a study description.

§ 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.