Manufacturer registered with FDA
BIO CONCEPT Co., Ltd
Changzhou, China. Lists 5 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 73
- 510(k) clearances
- 32015–2022
- Markets registered in
- 1United States
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Devices listed with FDA
What BIO CONCEPT 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 | BLT Dental Implant SystemBV Dental Implant SystemDental Implant System | 2015 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | BLT Dental Implant SystemBV Dental Implant SystemDental Implant System | 2015 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Anchor DrillAutoBone CollectorBone ProfilerBV Guide DrillCore DrillDome DrillExpander DrillExpanding DrillFlattening DrillGuide Drill 11 moreInitial DrillOsteotome Maxillary Sinus Elevation DrillPilot DrillProfile DrillScrew Removal DrillSide Wall DrillSR DrillTaper Cortical DrillTissue PunchTrephine DrillTwist Drill | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Anchor ScrewDigital AnalogDrill ExtenderDrill ExtensionDriverEsthetic-low Lab AnalogEsthetic-low Pick-up Impression CopingEsthetic-low Polishing ProtectorEsthetic-low Transfer Impression CopingExplantation Device 26 moreFixture DriverGuideGuide ScrewImpression CapImpression PostImpression Post Closed TrayMachine Screw DriverMetal SleeveMono ScanbodyMulti Abutment Outer DriverMulti Angled Abutment CarrierNoMount DriverNoMount Torque DriverOctagon Positioning CylinderPositioning CylinderPositioning JigScanbodyScrew Removal TipScrew-retained Abutment AnalogScrew-retained Abutment Digital AnalogSlot DriverSR TipTapTemplate Fixation PinTorque DriverTorque Extension | 2024 |
| Fixture Mount KitNYE · Class 1 | Implant instruments & surgical kits | Maker | BC Removal KitBL Mini KitBLT Guided KitBLT Mini KitBV Guided KitBV Mini KitBV Removal KitBV Standard KitNextra BLT Guided KitTL Mini Kit | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names BIO CONCEPT Co., Ltd as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIO CONCEPT CO., LTD.FDA reg. 3012465917 | Changzhou Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10050525). 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.