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K Number
K071386
Device Name
AMARIS/AMARIS FLOW
Manufacturer
VOCO GMBH
Date Cleared
2007-06-05

(18 days)

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

AMARIS/AMARIS FLOW is a light curing, radiopaque composite filling material for both anterior and posterior applications.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental filling material named Amaris/Amaris Flow. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The letter is an administrative notice of clearance, not a technical report or scientific study summary. It merely confirms that the device can be legally marketed based on its substantial equivalence to other devices, but it does not detail performance metrics, study designs, or ground truth establishment.

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