The following data is part of a premarket notification filed by M.i.s. Implants Technologies Ltd. with the FDA for Mistral - One Stage Screw-type Dental Implant, Model Mf9.
| Device ID | K070022 |
| 510k Number | K070022 |
| Device Name: | MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | M.I.S. IMPLANTS TECHNOLOGIES LTD. 278 BROADWAY Elmwood Park, NJ 07407 |
| Contact | Motti Weisman |
| Correspondent | Motti Weisman M.I.S. IMPLANTS TECHNOLOGIES LTD. 278 BROADWAY Elmwood Park, NJ 07407 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-03 |
| Decision Date | 2007-04-20 |
| Summary: | summary |