ULTRA-LITE 200E LIGHT CURE UNIT


Device Classification Name

activator, ultraviolet, for polymerization

510(k) Number K023545
Device Name ULTRA-LITE 200E LIGHT CURE UNIT
Original Applicant
ROLENCE ENT. INC.
18-3 lane 231 pu chung rd.
chungli, 

TW

320

Original Contact sterling cheng
Regulation Number 872.6070
Classification Product Code
EBZ  
Date Received 10/22/2002
Decision Date 12/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No