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K Number
K972355
Device Name
3M AURORA SYSTEM
Manufacturer
3M COMPANY
Date Cleared
1997-08-29

(65 days)

Product Code
EBZ
Regulation Number
872.6070
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The 3M™ Aurora System is indicated to activate a photochemical polymerization reaction in light cure dental materials.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is an FDA letter acknowledging a 510(k) submission for the "3M Aurora System" and stating that the device is substantially equivalent to previously marketed devices. It also includes the indications for use.

Therefore, I cannot extract any of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from this document.

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.