The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Carboxylate Cem, Phosphate Cem.
Device ID | K081702 |
510k Number | K081702 |
Device Name: | CARBOXYLATE CEM, PHOSPHATE CEM |
Classification | Cement, Dental |
Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
Contact | Christian Boettcher |
Correspondent | Christian Boettcher 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 | 2008-06-17 |
Decision Date | 2008-09-05 |
Summary: | summary |