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 |