FDA 510(k) Application Details - K012767

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K012767
Device Name	Material, Impression
Applicant	S & C POLYMER GMBH ROBERT-BOSCH-STRABE 5 ELMSHORN D-25335 DE Other 510(k) Applications for this Company
Contact	CHRISTIAN BOTTCHER Other 510(k) Applications for this Contact
Regulation Number	872.3660   More FDA Info for this Regulation Number
Classification Product Code	ELW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2001
Decision Date	11/01/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review