The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Ketac Applic-capsules.
| Device ID | K790832 |
| 510k Number | K790832 |
| Device Name: | KETAC APPLIC-CAPSULES |
| Classification | Cement, Dental |
| Applicant | ESPE GMBH (US) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-30 |
| Decision Date | 1979-04-30 |