SOLOCEM


Device Classification Name

cement, dental

510(k) Number K121621
Device Name SOLOCEM
Applicant
COLTENE/WHALEDENT AG
feldwiesenstrasse 20
altstatten, 

CH

ch-9450

Applicant Contact silke wallaschek
Correspondent
COLTENE/WHALEDENT AG
feldwiesenstrasse 20
altstatten, 

CH

ch-9450

Correspodent Contact silke wallaschek
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 06/01/2012
Decision Date 01/08/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No