Manufacturer registered with FDA
Hung Chun Bio-S Co., Ltd.
Kaohsiung City, Taiwan. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 11
- 510(k) clearances
- 22012–2018
- Markets registered in
- 1United States
- Establishments
- 1Taiwan
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Hung Chun Bio-S Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Ti-One 101 Dental Implant SystemTIONE 101 Dental Implant SystemTIONE TS Dental Implant System | 2012 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Bone Condenser (Straight/Curved)Extender, Torque Ratchet, Mini ScanbodyFinal Drill (Long/Short), Mini Final Drill, Final Drill Stopper, Tap, TS Tap, Mucosa PunchGuide Pin, Mini Guide Pin, Mini Angled Guide Pin, Path Pin, Depth GaugeHex Driver, Ratchet Hex Driver, Mini Ratchet Hex Driver, Screwman Ratchet Hex DriverLance, Mini Lance Drill, Lindemann, Pilot Drill, Round drill, Countersink, Mini Countersink DrillRatchet Adapter, Mini Ratchet Adapter, Handpiece Adapter, Mini Handpiece Adapter, Tap Adapter | 2018 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | TIONE TS Dental Implant System | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HUNG CHUN BIO-S CO., LTD.FDA reg. 3009761487 | Kaohsiung City, Taiwan | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10041652). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.