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K Number
K020342
Device Name
UNIFIL FLOW
Manufacturer
GC AMERICA, INC.
Date Cleared
2002-03-28

(55 days)

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

GC UniFil Flow is intended to be used for small class I & II :restora ions. · And Class III, IV and V restorations. Other uses include: Base and Liner, sealing for hypersensitivity, Pit and fissure sealar fixation of mobile teeth and repair of resin composite.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental material (GC UniFil Flow), indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and indications for use but does not present performance data or study details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text.

§ 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.