DUO TEMP


Device Classification Name

cement, dental

510(k) Number K072604
Device Name DUO TEMP
Applicant
COLTENE/WHALEDENT AG
1349 lexington avenue
new york, 
NY 
10128

Applicant Contact henry j vogelstein
Correspondent
COLTENE/WHALEDENT AG
1349 lexington avenue
new york, 
NY 
10128

Correspodent Contact henry j vogelstein
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 09/17/2007
Decision Date 11/16/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No