The following data is part of a premarket notification filed by Major Prodotti Dentari S.p.a. with the FDA for Major.repair.
| Device ID | K082153 |
| 510k Number | K082153 |
| Device Name: | MAJOR.REPAIR |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-30 |
| Decision Date | 2008-11-25 |
| Summary: | summary |