RESIN CEM


Device Classification Name

cement, dental

510(k) Number K011431
Device Name RESIN CEM
Original Applicant
S & C POLYMER GMBH
robert-bosch-strasse 5
elmshorn, 

DE

d-25335

Original Contact christian bottcher
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 05/09/2001
Decision Date 06/11/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No