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K Number
K994048
Device Name
PORTABLE LIGHT CURING UNIT
Manufacturer
GREGORY S. JACOB, D.D.S.
Date Cleared
2000-01-13

(48 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

This curing light unit is a source of illumination for the curing of dental restorative materials and is a source of illumination for tooth whitening materials used in dentistry.

Device Description

Portable Light Curing Unit

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a "Portable Light Curing Unit." It does not contain any information regarding acceptance criteria, device performance studies, or AI/algorithm-related details.

Therefore, I cannot fulfill your request using the provided text. The document is strictly an FDA clearance letter confirming substantial equivalence to a predicate device.

§ 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.