REMECURE MODEL CL 15E


Device Classification Name

activator, ultraviolet, for polymerization

510(k) Number K023652
Device Name REMECURE MODEL CL 15E
Original Applicant
REMEDENT NV
20992 bake pkwy.
unit 102
lake forest, 
CA 
92692

Original Contact ed first
Regulation Number 872.6070
Classification Product Code
EBZ  
Date Received 10/30/2002
Decision Date 01/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No