LED CURING LIGHT


Device Classification Name

activator, ultraviolet, for polymerization

510(k) Number K080035
Device Name LED CURING LIGHT
Applicant
MONITEX INDUSTRIAL CO., LTD.
6f, 70 sec. 1 guang-fu road
san-chung city, 

TW

241-58

Applicant Contact shu-lung wang
Correspondent
MONITEX INDUSTRIAL CO., LTD.
6f, 70 sec. 1 guang-fu road
san-chung city, 

TW

241-58

Correspodent Contact shu-lung wang
Regulation Number 872.6070
Classification Product Code
EBZ  
Date Received 01/07/2008
Decision Date 03/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No