The following data is part of a premarket notification filed by Adin Dental Implants Systems Ltd. with the FDA for Touareg Np Closefit Dental Implants System.
| Device ID | K140293 |
| 510k Number | K140293 |
| Device Name: | TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ADIN DENTAL IMPLANTS SYSTEMS LTD. ALON TAVOR INDUSTRIAL ZONE Pob 1128 Afula Elit, IL 1811101 |
| Contact | Nissim Shaked |
| Correspondent | Nissim Shaked ADIN DENTAL IMPLANTS SYSTEMS LTD. ALON TAVOR INDUSTRIAL ZONE Pob 1128 Afula Elit, IL 1811101 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-05 |
| Decision Date | 2014-10-31 |
| Summary: | summary |