The following data is part of a premarket notification filed by M.i.s. Implants Technologies Ltd. with the FDA for Uno - One Piece Screw-type Dental Implant.
| Device ID | K080162 |
| 510k Number | K080162 |
| Device Name: | UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | M.I.S. IMPLANTS TECHNOLOGIES LTD. P.O.B. 110 SHLOMI INDUSTRIAL ZONE Shlomi, IL 22832 |
| Contact | Iman Khorshid |
| Correspondent | Iman Khorshid M.I.S. IMPLANTS TECHNOLOGIES LTD. P.O.B. 110 SHLOMI INDUSTRIAL ZONE Shlomi, IL 22832 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-23 |
| Decision Date | 2008-04-22 |
| Summary: | summary |