BIO Concept Co., Ltd.
Manufacturer and brand owner in Changzhou, Jiangsu, China. 5 device types, 504 products catalogued, 3 clearances.
BIO Concept Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Fixture Mount Kit, Drill, Dental, Intraoral and 3 other device types. 300 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | BIO CONCEPT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012465917 |
| FEI number | 3012465917 |
| DUNS | 527603266 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 常州百康特医疗器械有限公司 |
|---|---|
| Unified social credit code | 913204116627407371 |
| Source | NMPA UDI database |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No.1019, Liaohe Road |
| Postal code | 213000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | Class 2 | BV Dental Implant System, Dental Implant System, BLT Dental Implant System | 2015 | 15 |
| Accessories, Implant, Dental, Endosseous | Class 1 | Template Fixation Pin, Tap, Drill Extension, Esthetic-low Transfer Impression Coping, Esthetic-low Polishing Protector, Metal Sleeve and 30 more | 2024 | 70 |
| Drill, Dental, Intraoral | Class 1 | Core Drill, Screw Removal Drill, Pilot Drill, Expander Drill, Profile Drill, Initial Drill and 15 more | 2024 | 20 |
| Fixture Mount Kit | Class 1 | BLT Guided Kit, Nextra BLT Guided Kit, BC Removal Kit, BL Mini Kit, BV Guided Kit, BLT Mini Kit and 4 more | 2024 | 2 |
| Implant, Endosseous, Root-Form | Class 2 | BV Dental Implant System, Dental Implant System, BLT Dental Implant System | 2015 | 7 |
Own-Brand Listings
Showing 250 of 300 products listed by this company.
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212364 | 2022-08-10 | DZE | Traditional | This company |
| K192274 | 2020-06-18 | DZE | Traditional | This company |
| K150388 | 2015-11-12 | DZE | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Employees | 80+ skilled technical professionals |
| Main products | Dental implants, Restoration components, Surgical instruments, Digital solutions, Treatment solutions |
| Certifications | Three-class medical device production license, CE certification, US FDA approval, Australian TGA certification, ISO 13485 |
| Export markets | 60+ countries and regions worldwide |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.