Data / Medical devices / Taiwan / Hung Chun Bio-S Co., Ltd.
Hung Chun Bio-S Co., Ltd.: FDA-registered device maker in Kaohsiung City, Taiwan, 2 510(k) clearances
Hung Chun Bio-S Co., Ltd. is registered with the FDA (registration 3009761487) in Kaohsiung City, Taiwan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 11, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009761487
- Address
- No.12, Luke 1st Rd., Luzhu Dist. Southern Taiwan Science Park, Kaohsiung City, Taiwan, 821
- Owner or operator
- HUNG CHUN BIO-S CO., LTD. (10041652)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- August 16, 2012
- Registered through
- 2026
- Brand names listed
- Bone Condenser (Straight/Curved), Extender, Torque Ratchet, Mini Scanbody, Final Drill (Long/Short), Mini Final Drill, Final Drill Stopper, Tap, TS Tap, Mucosa Punch, Guide Pin, Mini Guide Pin, Mini Angled Guide Pin, Path Pin, Depth Gauge, Hex Driver, Ratchet Hex Driver, Mini Ratchet Hex Driver, Screwman Ratchet Hex Driver, Lance, Mini Lance Drill, Lindemann, Pilot Drill, Round drill, Countersink, Mini Countersink Drill, Ratchet Adapter, Mini Ratchet Adapter, Handpiece Adapter, Mini Handpiece Adapter, Tap Adapter, TIONE 101 Dental Implant System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 11, 2018 | K172821 | Ti-one 101 TS Dental Implant System | DZE | Substantially Equivalent | Hung Chun Bio-S Co., Ltd. | accessdata.fda.gov |
| July 27, 2012 | K110425 | HC-BIOS DENTAL IMPLANT | DZE | Substantially Equivalent | Hung Chun Bio-S Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
Updated June 11, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.