COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM


Device Classification Name

adhesive, bracket and tooth conditioner, resin

510(k) Number K022224
Device Name COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
Original Applicant
COLTENE AG
750 corporate dr.
mahwah, 
NJ 
07430

Original Contact h.j. vogelstein
Regulation Number 872.3750
Classification Product Code
DYH  
Date Received 07/10/2002
Decision Date 09/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No