The following data is part of a premarket notification filed by T.f.i. System S.r.l with the FDA for Easy Grip Dental Implant System.
Device ID | K073622 |
510k Number | K073622 |
Device Name: | EASY GRIP DENTAL IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | T.F.I. SYSTEM S.R.L VIA ALESSANDRO D'ANCONA 23 Roma (rm), IT 00137 |
Contact | Dott. Claudio Mechelli |
Correspondent | Dott. Claudio Mechelli T.F.I. SYSTEM S.R.L VIA ALESSANDRO D'ANCONA 23 Roma (rm), IT 00137 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-26 |
Decision Date | 2008-05-14 |
Summary: | summary |