TOESCO AQUA BLUE LED LIGHT CURING DEVICE


Device Classification Name

activator, ultraviolet, for polymerization

510(k) Number K021374
Device Name TOESCO AQUA BLUE LED LIGHT CURING DEVICE
Original Applicant
TOEI ELECTRIC CO., LTD.
55 northern blvd.
suite 200
great neck, 
NY 
11021

Original Contact susan d goldstein-falk
Regulation Number 872.6070
Classification Product Code
EBZ  
Date Received 05/01/2002
Decision Date 05/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No