Q-LUX LIGHT CURE UNIT


Device Classification Name

activator, ultraviolet, for polymerization

510(k) Number K960351
Device Name Q-LUX LIGHT CURE UNIT
Applicant
ROLENCE ENTERPRISE CO. LTD.
226 kong-shieh-sir village
chungli, taiwan r.o.c., 

TW

Applicant Contact sterling cheng
Correspondent
ROLENCE ENTERPRISE CO. LTD.
226 kong-shieh-sir village
chungli, taiwan r.o.c., 

TW

Correspodent Contact sterling cheng
Regulation Number 872.6070
Classification Product Code
EBZ  
Date Received 01/25/1996
Decision Date 04/15/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No