COOLBLU2 DENTAL RESIN CURING DEVICE


Device Classification Name

activator, ultraviolet, for polymerization

510(k) Number K020171
Device Name COOLBLU2 DENTAL RESIN CURING DEVICE
Original Applicant
DENTAL SYSTEMS.COM, INC.
1187 tadsworth terrace
heathrow, 
FL 
32746

Original Contact shinobu doi
Regulation Number 872.6070
Classification Product Code
EBZ  
Date Received 01/17/2002
Decision Date 01/29/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No