The following data is part of a premarket notification filed by Mis Implants Technologies Ltd. with the FDA for Mis Lockit Abutments System, Ot-equators And Ball Attachments.
| Device ID | K182228 |
| 510k Number | K182228 |
| Device Name: | MIS LOCKiT Abutments System, OT-Equators And Ball Attachments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park Bar Lev Industrial Park, IL 2015600 |
| Contact | Arbel Shezaf |
| Correspondent | Arbel Shezaf MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park Bar Lev Industrial Park, IL 2015600 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-16 |
| Decision Date | 2019-01-28 |
| Summary: | summary |