The following data is part of a premarket notification filed by Major Prodotti Dentari S.p.a. with the FDA for Temporary Cold.v And Self-cure Dentine.
| Device ID | K082700 |
| 510k Number | K082700 |
| Device Name: | TEMPORARY COLD.V AND SELF-CURE DENTINE |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | MAJOR PRODOTTI DENTARI S.P.A. VIA LUIGI EINAUDI 23 Monacalieri (torino), IT I-10024 |
| Contact | Monica Funai |
| Correspondent | Monica Funai MAJOR PRODOTTI DENTARI S.P.A. VIA LUIGI EINAUDI 23 Monacalieri (torino), IT I-10024 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-15 |
| Decision Date | 2008-12-09 |
| Summary: | summary |