The following data is part of a premarket notification filed by Dreve Dentamid Gmbh with the FDA for Nano Varnish, Plaquit, Lightpaint On Surface.
| Device ID | K162408 |
| 510k Number | K162408 |
| Device Name: | Nano Varnish, Plaquit, Lightpaint On Surface |
| Classification | Coating, Filling Material, Resin |
| Applicant | DREVE DENTAMID GMBH MAX-PLANCK-STRASSE 31 Unna, DE 59423 |
| Contact | Reiner Altmann |
| Correspondent | Reiner Altmann DREVE DENTAMID GMBH MAX-PLANCK-STRASSE 31 Unna, DE 59423 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-29 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E239D389001 | K162408 | 000 |
| E239D382391 | K162408 | 000 |
| E239D381241 | K162408 | 000 |
| E239D381231 | K162408 | 000 |
| E239D38900US1 | K162408 | 000 |