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K Number
K030811
Device Name
COOL CURE
Manufacturer
SAMM, INC.
Date Cleared
2003-06-10

(89 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 dialal curing light and accessories, Cool Cure, is used to provide a source of illumination for curing dental restorative matcrials in the mouth.

Device Description

Cool Cure, Dental Curing Light and Accessories

AI/ML Overview

I am sorry, but based on the text provided, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental curing light, and it does not contain the detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications that you are asking for.

The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is a regulatory pathway, not a detailed scientific study report demonstrating performance against specific acceptance criteria.

§ 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.