LogoFDA 510(k) Search
K Number
K020877
Device Name
EXCELLITE TURBO LIGHT CURE UNIT
Manufacturer
ROLENCE ENT. INC.
Date Cleared
2002-06-12

(86 days)

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

THE EXCELLITE TURBO IS A.LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS.

Device Description

EXCELLITE TURBO LIGHT CURE UNIT

AI/ML Overview

This looks like a 510(k) clearance letter for a dental light cure unit, not a study report for an AI device. The document does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria.

Specifically, the device is the "Excellite Turbo Light Cure Unit" and its indication for use is "for polymerization of light cured material by dental professionals." This is a physical device used for dental procedures, not an AI or software-as-a-medical-device (SaMD).

Therefore, I cannot provide the requested information based on the provided text. The questions you've asked are relevant for AI/SaMD submissions, but not for this type of traditional medical device clearance.

§ 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.