The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Ketac Cem U.
| Device ID | K002793 |
| 510k Number | K002793 |
| Device Name: | KETAC CEM U |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-07 |
| Decision Date | 2000-09-26 |