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K Number
K103580
Device Name
GRANDIO SO FLOW
Manufacturer
VOCO GMBH
Date Cleared
2011-01-21

(46 days)

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

Grandio SO Flow is intended for use as:

  • filling minimally invasive cavities of all classes -
  • filling small class I cavities and extended fissure sealing -
  • filling class II V cavities including V-shaped defects and cervical caries -
  • blocking out undercuts -
  • lining or coating cavities .
  • repairing fillings and veneers -
  • luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.)
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text only contains an FDA 510(k) clearance letter for a dental material (Grandio SO Flow), which is a physical device, not an AI/ML-driven device. As such, the document does not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance. Therefore, I cannot fulfill your request based on the given 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.