The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Impregum Penta M Monosoft.
| Device ID | K994192 |
| 510k Number | K994192 |
| Device Name: | IMPREGUM PENTA M MONOSOFT |
| Classification | Material, Impression |
| Applicant | ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Contact | Andreas Petermann |
| Correspondent | Andreas Petermann ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-13 |
| Decision Date | 2000-01-28 |
| Summary: | summary |