The following data is part of a premarket notification filed by Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. with the FDA for Implance Dental Implant System, Implance Dental Abutment System.
| Device ID | K160221 |
| 510k Number | K160221 |
| Device Name: | Implance Dental Implant System, Implance Dental Abutment System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. Mahmut Yesari Caddesi No: 25 Istanbul, TR 34718 |
| Contact | Gorkem Serce |
| Correspondent | H. Semih Oktay CardioMed Device Consultants, LLC 5523 Research Park Drive Suite 205 Baltimore, MD 21228 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-29 |
| Decision Date | 2016-09-12 |
| Summary: | summary |