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K Number
K020874
Device Name
ULTRA-LITE 5 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 ULTRA-LITE 5 TURBO IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS .

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a dental light cure unit. It confirms that the device is substantially equivalent to a legally marketed predicate device and allows it to be marketed.

However, this document does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or clinical performance data as you have requested. These details would typically be found in the 510(k) submission itself, which is a much more extensive document than the clearance letter.

Therefore, I cannot extract the information you are looking for from the given text.

§ 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.