FDA Registration
Active
🇨🇳 China
BIO CONCEPT CO., LTD.
Reg #: 3012465917
·
FEI: 3012465917
·
Expires 2026
Products
5
Proprietary Names
68
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- BIO CONCEPT CO., LTD.
- Registration Number
- 3012465917
- FEI Number
- 3012465917
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.1019, Liaohe Road, Xinbei District
- City
- Changzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K192274
Owner / Operator
- Firm Name
- BIO CONCEPT Co., Ltd
- Operator Number
- 10050525
- Address
- No.1019, Liaohe Road, Xinbei District
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213000
- Country
- CN
US Agent
- Business Name
- MID-LINK INTERNATIONAL CO., LTD
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2024-09-12 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2020-07-02 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2020-07-02 |
| Fixture Mount Kit | NYE | Class 1 | Dental | No | 2024-09-13 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2024-09-12 |
Proprietary Names
Torque Driver
NoMount Driver
Screw-retained Abutment Digital Analog
Guide Screw
Multi Angled Abutment Carrier
Drill Extender
Esthetic-low Lab Analog
Esthetic-low Pick-up Impression Coping
Impression Post Closed Tray
Fixture Driver
Scanbody
Esthetic-low Transfer Impression Coping
SR Tip
Machine Screw Driver
Torque Extension
Slot Driver
Drill Extension
Esthetic-low Polishing Protector
NoMount Torque Driver
Mono Scanbody
Explantation Device
Positioning Cylinder
Multi Abutment Outer Driver
Anchor Screw
Screw Removal Tip
Digital Analog
Guide
Driver
Metal Sleeve
Octagon Positioning Cylinder
Tap
Impression Post
Screw-retained Abutment Analog
Template Fixation Pin
Impression Cap
Positioning Jig
BV Dental Implant System
BLT Dental Implant System
Dental Implant System
BC Removal Kit
BLT Guided Kit
BV Standard Kit
BV Removal Kit
TL Mini Kit
BV Guided Kit
BV Mini Kit
BLT Mini Kit
BL Mini Kit
Profile Drill
Anchor Drill
Side Wall Drill
Guide Drill
Flattening Drill
Initial Drill
SR Drill
Tissue Punch
Twist Drill
Osteotome Maxillary Sinus Elevation Drill
AutoBone Collector
Taper Cortical Drill
Core Drill
BV Guide Drill
Bone Profiler
Expander Drill
Pilot Drill
Screw Removal Drill
Dome Drill
Trephine Drill
Establishment Types
Manufacture Medical Device