The following data is part of a premarket notification filed by Micerium S.p.a. with the FDA for Ena Temp And Enamel Plus Temp (two Different Proprietary Names For The Same Product).
| Device ID | K103474 |
| 510k Number | K103474 |
| Device Name: | ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | MICERIUM S.P.A. VIA MARCONI 83 Avengo, IT 16030 |
| Contact | Ssa Carla Tazzer |
| Correspondent | Ssa Carla Tazzer MICERIUM S.P.A. VIA MARCONI 83 Avengo, IT 16030 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-26 |
| Decision Date | 2011-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EMICTEMPL1 | K103474 | 000 |
| EMICTEMP1NOF1 | K103474 | 000 |
| EMICTEMP1N1 | K103474 | 000 |