The following data is part of a premarket notification filed by Dmg Chemisch-pharmazeutische Fabrik Gmbh with the FDA for Deltafil, Deltafil Conditioner.
| Device ID | K213201 |
| 510k Number | K213201 |
| Device Name: | DeltaFil, DeltaFil Conditioner |
| Classification | Cement, Dental |
| Applicant | DMG Chemisch-Pharmazeutische Fabrik GmbH Elbgaustrasse 248 Hamburg, DE 22547 |
| Contact | Stephan Schaefer |
| Correspondent | Pamela Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave Ayer, MA 01432 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2022-06-01 |