The following data is part of a premarket notification filed by Mis Implants Technologies Ltd. with the FDA for Conical Connection Implants.
| Device ID | K112162 |
| 510k Number | K112162 |
| Device Name: | CONICAL CONNECTION IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MIS IMPLANTS TECHNOLOGIES LTD. BAR LEV INDUSTRIAL PARK P.O. BOX 7 Bar Lev Industrial Park, IL 20156 |
| Contact | Iman Khorshid |
| Correspondent | Iman Khorshid MIS IMPLANTS TECHNOLOGIES LTD. BAR LEV INDUSTRIAL PARK P.O. BOX 7 Bar Lev Industrial Park, IL 20156 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-27 |
| Decision Date | 2012-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290113996243 | K112162 | 000 |
| 07290113996076 | K112162 | 000 |
| 07290113996083 | K112162 | 000 |
| 07290113996106 | K112162 | 000 |
| 07290113996113 | K112162 | 000 |
| 07290113996120 | K112162 | 000 |
| 07290113996144 | K112162 | 000 |
| 07290113996151 | K112162 | 000 |
| 07290113996168 | K112162 | 000 |
| 07290113996182 | K112162 | 000 |
| 07290113996199 | K112162 | 000 |
| 07290113996205 | K112162 | 000 |
| 07290113996229 | K112162 | 000 |
| 07290113996236 | K112162 | 000 |
| 07290113996069 | K112162 | 000 |