The following data is part of a premarket notification filed by 3m Deutschland Gmbh with the FDA for Ketac Universal Aplicap.
| Device ID | K153174 |
| 510k Number | K153174 |
| Device Name: | Ketac Universal Aplicap |
| Classification | Cement, Dental |
| Applicant | 3M DEUTSCHLAND GMBH ESPE PLATZ Seefeld, DE 82229 |
| Contact | Ruediger Franke |
| Correspondent | Ruediger Franke 3M DEUTSCHLAND GMBH ESPE PLATZ Seefeld, DE 82229 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-03 |
| Decision Date | 2016-04-13 |
| Summary: | summary |