The following data is part of a premarket notification filed by Sanlilar Tibbi Cihazlar Med. Kim.san.tic.ltd.sti with the FDA for Nucleoss Tpure Implant System.
| Device ID | K160850 |
| 510k Number | K160850 |
| Device Name: | Nucleoss Tpure Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SANLILAR TIBBI CIHAZLAR MED. KIM.SAN.TIC.LTD.STI 10018 SOK. NO 7 ITOB ORGANIZE SANAYI Bolgesi Tekeli, TR Tr-35477 |
| Contact | Ezgi Erdem |
| Correspondent | H.semih Oktay REGISTRAR CORP 1783 Forest Drive #254 Annapolis, MD 21401 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-28 |
| Decision Date | 2017-08-04 |
| Summary: | summary |