Data / Medical devices / China / Bio Concept Co., Ltd.
Bio Concept Co., Ltd.: FDA-registered device maker in Changzhou Jiangsu, China, 3 510(k) clearances
Bio Concept Co., Ltd. is registered with the FDA (registration 3012465917) in Changzhou Jiangsu, China. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 10, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012465917
- Address
- No.1019, Liaohe Road Xinbei District, Changzhou Jiangsu, China, 213000
- Owner or operator
- BIO CONCEPT Co., Ltd (10050525)
- Roles
- Manufacturer
- First device listed
- November 29, 2015
- Registered through
- 2027
- Brand names listed
- Anchor Drill, Anchor Screw, AutoBone Collector, BC Removal Kit, BL Mini Kit, BLT Dental Implant System, BLT Guided Kit, BLT Mini Kit 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 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Fixture Mount Kit | NYE | 1 | 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 |
|---|---|---|---|---|---|---|
| August 10, 2022 | K212364 | BLT Dental Implant System | DZE | Substantially Equivalent | Bio Concept Co., Ltd. | accessdata.fda.gov |
| June 18, 2020 | K192274 | BV Dental Implant System | DZE | Substantially Equivalent | Bio Concept Co., Ltd. | accessdata.fda.gov |
| November 12, 2015 | K150388 | Dental Implant System | DZE | Substantially Equivalent | Bio Concept Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Drill, Dental, Intraoral
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Fixture Mount Kit
- All makers of Accessories, Implant, Dental, Endosseous
Updated August 10, 2022. 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.