ONE COAT SE BOND

Device Classification Name

agent, tooth bonding, resin

510(k) Number K033760
Device Name ONE COAT SE BOND
Applicant
COLTENE/WHALEDENT INC.
1349 lexington ave.
new york, 
NY 
10128

Applicant Contact henry j vogelstein
Correspondent
COLTENE/WHALEDENT INC.
1349 lexington ave.
new york, 
NY 
10128

Correspodent Contact henry j vogelstein
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 12/02/2003
Decision Date 01/23/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No