The following data is part of a premarket notification filed by Espe Dental Products with the FDA for Ketac-cem In Ref. To K802048.
| Device ID | K802819 |
| 510k Number | K802819 |
| Device Name: | KETAC-CEM IN REF. TO K802048 |
| Classification | Cement, Dental |
| Applicant | ESPE DENTAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-07 |
| Decision Date | 1980-11-24 |