The following data is part of a premarket notification filed by Dreve Dentamid Gmbh with the FDA for Fixtemp C&b.
| Device ID | K171729 |
| 510k Number | K171729 |
| Device Name: | Fixtemp C&B |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Dreve Dentamid GmbH Max-Planck-StraBe 31 Unna, DE 59423 |
| Contact | Reiner Altmann |
| Correspondent | Reiner Altmann Dreve Dentamid GmbH Max-Planck-StraBe 31 Unna, DE 59423 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-12 |
| Decision Date | 2017-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E239D603991 | K171729 | 000 |
| E239D603961 | K171729 | 000 |
| E239D603951 | K171729 | 000 |
| E239D603941 | K171729 | 000 |
| E239D6039351 | K171729 | 000 |
| E239D603931 | K171729 | 000 |
| E239D6039251 | K171729 | 000 |
| E239D603921 | K171729 | 000 |
| E239D603911 | K171729 | 000 |