The following data is part of a premarket notification filed by Micerium S.p.a. with the FDA for Ena Cem.
| Device ID | K062355 |
| 510k Number | K062355 |
| Device Name: | ENA CEM |
| Classification | Cement, Dental |
| Applicant | MICERIUM S.P.A. VIA MARCONI 83 Avengo, IT 16030 |
| Contact | Eugenio Miceli |
| Correspondent | Eugenio Miceli MICERIUM S.P.A. VIA MARCONI 83 Avengo, IT 16030 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-14 |
| Decision Date | 2006-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EMICCPCZK1 | K062355 | 000 |
| EMICCPCK1 | K062355 | 000 |