The following data is part of a premarket notification filed by Hung Chun Bio-s Co.,ltd. with the FDA for Ti-one 101 Ts Dental Implant System.
| Device ID | K172821 |
| 510k Number | K172821 |
| Device Name: | Ti-one 101 TS Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Hung Chun Bio-S Co.,Ltd. No.12, Luke 1st Rd., Luzhu Dist., Kaohsiung City, TW 821 |
| Contact | Jethro Liou |
| Correspondent | Allison Liu Hung Chun Bio-S Co.,Ltd. No.12, Luke 1st Rd., Luzhu Dist., Kaohsiung City, TW 821 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2018-06-11 |
| Summary: | summary |