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High-speed Air Turbine Handpieces
EUDAMEDFDA 510(k)FDA UDIClass IIa (EU MDR)
Ref H01-SPModel CX207510(k) K220179Ref H17-TP4Model CX207-WRef H33-TP4Model CX207-BRef H01-SP4Ref H14-SP4Model CX207-CRef H05-MPQ4Model CX207-FRef H33-SP2Model CX207-B-2Ref M-3B-4Model CX235-3BRef H01-D1SP4Ref H13-SP4Ref H17-SPQ4Ref H15-TPQ4
Identity
- Trade Name
- COXO FDA UDI
- Generic Name
- Dental surgical power tool motor, pneumatic FDA UDI
- Device Name
- High-speed Air Turbine Handpieces EUDAMEDFDA UDIAir Motors EUDAMEDFDA UDI
- Model / Reference
- CX207 EUDAMEDFDA UDIH01-SP EUDAMEDCX207-W EUDAMEDFDA UDICX235-3B EUDAMEDFDA UDIH17-TP4 EUDAMEDCX207-B EUDAMEDH33-TP4 EUDAMEDH01-SP4 EUDAMEDCX207-C EUDAMEDH14-SP4 EUDAMEDCX207-F EUDAMEDH05-MPQ4 EUDAMEDCX207-B-2 EUDAMEDH33-SP2 EUDAMEDM-3B-4 EUDAMEDH01-D1SP4 EUDAMEDH13-SP4 EUDAMEDH17-SPQ4 EUDAMEDH15-TPQ4 EUDAMED
- Description
- High-Speed Air Turbine Handpieces FDA UDIAir Motors FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974267890015 EUDAMED06974267891296 EUDAMEDFDA UDI06974267890336 EUDAMEDFDA UDI06974267891302 EUDAMEDFDA UDI06974267891555 EUDAMED06974267891586 EUDAMED06974267890077 EUDAMED06974267890923 EUDAMED06974267891562 EUDAMED06974267890053 EUDAMED06974267890930 EUDAMED
- Basic UDI-DI
- B-06974267890015 EUDAMEDB-06974267891555 EUDAMEDB-06974267891586 EUDAMEDB-06974267890077 EUDAMEDB-06974267890923 EUDAMEDB-06974267891562 EUDAMEDB-06974267890336 EUDAMEDB-06974267891302 EUDAMEDB-06974267890053 EUDAMEDB-06974267891296 EUDAMEDB-06974267890930 EUDAMED
- 510(k) Number
- FDA Product Code
- EFB FDA 510(k)FDA UDIEGS FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Dental surgical power tool motor, pneumatic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.4200 FDA 510(k)
- Regulation Number
- 872.4200 FDA 510(k)FDA UDI
- Market of Registration
- France EUDAMEDPoland EUDAMEDPortugal EUDAMEDFinland EUDAMEDRomania EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
High-speed Air Turbine Handpieces by Foshan COXO Medical Instrument Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220179 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06974267890015 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan COXO Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000001682
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (16)
- EUDAMED 3ba6229e-dcee-48ff-b851-020e9d2b7687 61 fields · synced Oct 6, 2026
- FDA 510(k) K220179 24 fields · synced May 18, 2026
- FDA UDI 36c6f57f-0aec-4537-aa26-57ede499516e 34 fields · synced May 29, 2026
- FDA UDI 21f6b83b-2e54-4a36-873d-5994cb24ada3 34 fields · synced May 30, 2026
- FDA UDI 83b93559-98d3-45d1-8eca-07442cb5f3da 34 fields · synced May 30, 2026
- EUDAMED 077c9afe-57c2-41a7-8dd8-e8469566c605 61 fields · synced Jul 9, 2026
- EUDAMED c1092138-e648-4d48-a377-ab89d736f93d 61 fields · synced Jul 9, 2026
- EUDAMED e03eb338-8552-4b4e-96b8-1e7ba09086c5 61 fields · synced Jul 10, 2026
- EUDAMED ef5b8467-f066-4ca8-83d2-88a23f9d56b1 61 fields · synced Jul 11, 2026
- EUDAMED 9ce928db-88aa-471f-9439-ea6fcfc3dcfd 61 fields · synced Jul 11, 2026
- EUDAMED 4bbeedf8-c9e5-4256-81bc-da23959f0821 61 fields · synced Jul 20, 2026
- EUDAMED db78c08a-47b1-47c2-adfe-7a4d09547dc6 61 fields · synced Jul 23, 2026
- EUDAMED c26f0b03-e62c-4b4e-902f-58b83bd267b6 61 fields · synced Jul 30, 2026
- EUDAMED 484dc898-de54-46b5-8e09-f3e917e30741 61 fields · synced Aug 3, 2026
- EUDAMED 7cc7d566-7138-462d-bf88-114542d361cc 61 fields · synced Aug 3, 2026
- EUDAMED 462f35ec-4f32-4884-8ed1-d89591dfbccc 61 fields · synced Oct 1, 2026