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K Number
K013400
Device Name
SYNERGY FLOW
Manufacturer
COLTENE/WHALEDENT INC.
Date Cleared
2001-12-10

(56 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

Class II, IV fillings in anterior teeth; Small fillings in posterior teeth; Fillings of minimal cavities; Blocking out undercuts

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental device called "Synergy Flow." It does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its intended uses.

Therefore, I cannot provide the requested information based on this 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.