The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Ketac-cem Maxicap.
| Device ID | K897188 |
| 510k Number | K897188 |
| Device Name: | KETAC-CEM MAXICAP |
| Classification | Cement, Dental |
| Applicant | ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Contact | Harold A Opotow |
| Correspondent | Harold A Opotow ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-28 |
| Decision Date | 1990-03-27 |