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K Number
K020171
Device Name
COOLBLU2 DENTAL RESIN CURING DEVICE
Manufacturer
DENTAL SYSTEMS.COM, INC.
Date Cleared
2002-01-29

(12 days)

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

The CoolBlu2 curing light is intended as a source of illumination for the curing of dental restorative materials.

Device Description

CoolBlu2 Dental Resin Curing Device

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the CoolBlu2 Dental Resin Curing Device. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested table and details based on the given input. The letter is a regulatory approval document, not a scientific study report.

§ 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.