The following data is part of a premarket notification filed by Mis Implants Technologies Ltd. with the FDA for Mis C1 Narrow Platform Conical Connection Implant System, Mis C1 Wide Platform Conical Connection Abutments.
| Device ID | K172505 |
| 510k Number | K172505 |
| Device Name: | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park Bar Lev Industrial Park, IL 2015600 |
| Contact | Arbel Shezaf |
| Correspondent | Randy Prebula Hogan Lovells US LLP 555 13th Street, NW Washington, D.c, DC 20004 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-18 |
| Decision Date | 2017-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109005737 | K172505 | 000 |
| 07290109003832 | K172505 | 000 |
| 07290108994544 | K172505 | 000 |
| 07290108994537 | K172505 | 000 |
| 07290108994520 | K172505 | 000 |
| 07290108994513 | K172505 | 000 |