The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Dc Provi Cem Esthetic, Esthetic Multi F, Implant.
| Device ID | K091735 |
| 510k Number | K091735 |
| Device Name: | DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT |
| 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 | 2009-06-11 |
| Decision Date | 2009-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBIB037301 | K091735 | 000 |