SAVEDENT BLUE

Activator, Ultraviolet, For Polymerization

DENFOTEX LIGHT SYSTEMS LTD

The following data is part of a premarket notification filed by Denfotex Light Systems Ltd with the FDA for Savedent Blue.

Pre-market Notification Details

Device IDK042196
510k NumberK042196
Device Name:SAVEDENT BLUE
ClassificationActivator, Ultraviolet, For Polymerization
Applicant DENFOTEX LIGHT SYSTEMS LTD UNIT 15, BELLEKNOWES IND.EST Inverkeithing Fife, Scotland,  GB Ky11 1h7
ContactJohn Colles
CorrespondentWilliam J Sammons
UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle,  NC  27709
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-08-13
Decision Date2004-11-01
Summary:summary

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