The following data is part of a premarket notification filed by Major Prodotti Dentari S.p.a. with the FDA for Major.base 20.
Device ID | K081884 |
510k Number | K081884 |
Device Name: | MAJOR.BASE 20 |
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 | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-02 |
Decision Date | 2008-10-08 |
Summary: | summary |