The following data is part of a premarket notification filed by Mis - Implant Technologies Ltd. with the FDA for Mis Dental Implant System.
| Device ID | K040807 |
| 510k Number | K040807 |
| Device Name: | MIS DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MIS - IMPLANT TECHNOLOGIES LTD. 278 BROADWAY Elmwood Park, NJ 07407 |
| Contact | Motti Weisman |
| Correspondent | Motti Weisman MIS - IMPLANT TECHNOLOGIES LTD. 278 BROADWAY Elmwood Park, NJ 07407 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-29 |
| Decision Date | 2004-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290113993617 | K040807 | 000 |
| 07290109004242 | K040807 | 000 |
| 07290109002668 | K040807 | 000 |
| 07290109002651 | K040807 | 000 |