Q-LUX LIGHT CURE UNIT

Activator, Ultraviolet, For Polymerization

ROLENCE ENTERPRISE CO. LTD.

The following data is part of a premarket notification filed by Rolence Enterprise Co. Ltd. with the FDA for Q-lux Light Cure Unit.

Pre-market Notification Details

Device IDK960351
510k NumberK960351
Device Name:Q-LUX LIGHT CURE UNIT
ClassificationActivator, Ultraviolet, For Polymerization
Applicant ROLENCE ENTERPRISE CO. LTD. 226 KONG-SHIEH-SIR VILLAGE Chungli, Taiwan R.o.c.,  TW
ContactSterling Cheng
CorrespondentSterling Cheng
ROLENCE ENTERPRISE CO. LTD. 226 KONG-SHIEH-SIR VILLAGE Chungli, Taiwan R.o.c.,  TW
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-25
Decision Date1996-04-15

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