The following data is part of a premarket notification filed by Dreve Dentamid Gmbh with the FDA for Stonebite And Stonebite Scan.
| Device ID | K190571 |
| 510k Number | K190571 |
| Device Name: | StoneBite And StoneBite Scan |
| Classification | Material, Impression |
| 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 | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-06 |
| Decision Date | 2019-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E239D5048731 | K190571 | 000 |
| E239D5048721 | K190571 | 000 |
| E239D5048701 | K190571 | 000 |
| E239D504872A1 | K190571 | 000 |