The following data is part of a premarket notification filed by Micerium S.p.a. with the FDA for Miniscrews Anchoring System, M.a.s..
Device ID | K062367 |
510k Number | K062367 |
Device Name: | MINISCREWS ANCHORING SYSTEM, M.A.S. |
Classification | Implant, Endosseous, Root-form |
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 | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-14 |
Decision Date | 2006-12-08 |
Summary: | summary |