The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Procem.
| Device ID | K984248 |
| 510k Number | K984248 |
| Device Name: | PROCEM |
| Classification | Cement, Dental |
| Applicant | ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Contact | Andrea Petermann |
| Correspondent | Andrea Petermann ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-27 |
| Decision Date | 1999-01-08 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PROCEM 75594644 2396966 Dead/Cancelled |
CENTRE STEPHANOIS DE RECHERCHES MECANIQUES HYDROMECANIQUE ET FROTTEMENT 1998-11-24 |
![]() PROCEM 75356361 2601343 Live/Registered |
HOLCIM (US) INC. 1997-08-27 |
![]() PROCEM 75075084 2088858 Dead/Cancelled |
THERA Patent GmbH & Co. KG Gesellschaftfur Industrielle Schurtzrechte 1996-03-19 |