The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Impregum Penta.
Device ID | K992897 |
510k Number | K992897 |
Device Name: | IMPREGUM PENTA |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-27 |
Decision Date | 1999-09-08 |
Summary: | summary |