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K Number
K062343
Device Name
GRANDIO FLOW TRY-IN
Manufacturer
VOCO GMBH
Date Cleared
2006-11-02

(83 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 Flow Try-In assists the dentist in selecting the correct shade for cementing with Grandio Flow Try-In assists the dentist in oblocing the other watch the shades of polymerized Grandio Flow composites.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a dental material (Grandio Flow Try-In). It does not contain information about acceptance criteria or a study proving a device meets such criteria for an AI/ML powered device. The letter is for a physical dental product and not a software device that would typically have the kind of performance metrics you are asking about.

Therefore, I cannot provide the requested information based on the given document.

§ 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.