AGC CEM


Device Classification Name

cement, dental

510(k) Number K030168
Device Name AGC CEM
Original Applicant
WIELAND DENTAL + TECHNIK GMBH & CO. KG
schwenninger strabe 13
pforzheim, 

DE

d-75179

Original Contact gerhard polzer
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 01/17/2003
Decision Date 03/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No