The following data is part of a premarket notification filed by Mis Implants Technologies Ltd. with the FDA for Mis Connect Conical Connection Abutment.
| Device ID | K173326 |
| 510k Number | K173326 |
| Device Name: | MIS CONNECT Conical Connection Abutment |
| 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 | Noa Ofer |
| Correspondent | Randy Prebula Hogan Lovells US LLP 555 13th St. NW Washington, DC 20004 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-20 |
| Decision Date | 2018-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109004679 | K173326 | 000 |
| 07290113990562 | K173326 | 000 |
| 07290113990579 | K173326 | 000 |
| 07290109004426 | K173326 | 000 |
| 07290109004433 | K173326 | 000 |
| 07290109004440 | K173326 | 000 |
| 07290109004457 | K173326 | 000 |
| 07290109004464 | K173326 | 000 |
| 07290109004471 | K173326 | 000 |
| 07290109004488 | K173326 | 000 |
| 07290109004495 | K173326 | 000 |
| 07290109004501 | K173326 | 000 |
| 07290109004518 | K173326 | 000 |
| 07290109004600 | K173326 | 000 |
| 07290109004617 | K173326 | 000 |
| 07290109004648 | K173326 | 000 |
| 07290109004655 | K173326 | 000 |
| 07290109004662 | K173326 | 000 |
| 07290109004631 | K173326 | 000 |