K172821 is an FDA 510(k) clearance for the Ti-one 101 TS Dental Implant System. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Hung Chun Bio-S Co., Ltd. (Kaohsiung, TW). The FDA issued a Cleared decision on June 11, 2018, 266 days after receiving the submission on September 18, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K172821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2017 |
| Decision Date | June 11, 2018 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE — Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |