The following data is part of a premarket notification filed by Adin Dental Implants System Ltd with the FDA for Touareg Closefit Dental Impant System.
| Device ID | K112585 |
| 510k Number | K112585 |
| Device Name: | TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ADIN DENTAL IMPLANTS SYSTEM LTD INDUSTRIAL ZONE ALON TAVOR, P.O. BOX 1128 Afula, IL 20187 |
| Contact | Yana Prus-galynsky |
| Correspondent | Yana Prus-galynsky ADIN DENTAL IMPLANTS SYSTEM LTD INDUSTRIAL ZONE ALON TAVOR, P.O. BOX 1128 Afula, IL 20187 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-06 |
| Decision Date | 2012-05-24 |
| Summary: | summary |