The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Classic Cem.
Device ID | K011064 |
510k Number | K011064 |
Device Name: | CLASSIC CEM |
Classification | Cement, Dental |
Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
Contact | Jurgen Engelbrecht |
Correspondent | Jurgen Engelbrecht S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-04-06 |
Decision Date | 2001-05-17 |