The following data is part of a premarket notification filed by Mis - Implant Technologies Ltd. with the FDA for Seven Implants; Biocom Implants; Lance Implants.
| Device ID | K103089 |
| 510k Number | K103089 |
| Device Name: | SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MIS - IMPLANT TECHNOLOGIES LTD. BAR LEV INDUSTRIAL PARK P.O. BOX 7 Bar Lev Industrial Park, IL 20156 |
| Contact | Iman Khorshid |
| Correspondent | Iman Khorshid MIS - IMPLANT 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 | 2010-10-19 |
| Decision Date | 2011-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290113997677 | K103089 | 000 |
| 07290113997660 | K103089 | 000 |