The following data is part of a premarket notification filed by Dreve Dentamid Gmbh with the FDA for Fotodent Denture.
| Device ID | K200580 |
| 510k Number | K200580 |
| Device Name: | FotoDent Denture |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Dreve Dentamid GmbH Max-Planck-Strasse 31 Unna, DE 59423 |
| Contact | Reiner Altmann |
| Correspondent | Nevine Erian BQC Consulting LLC 24341 Barbados Dr. Dana Point, CA 92629 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-05 |
| Decision Date | 2020-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E239D355011 | K200580 | 000 |
| E239D355001 | K200580 | 000 |