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Dental Electrical Motors
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref SRCT2000Model iRoot pro
Identity
- Trade Name
- Dental Electrical Motors EUDAMED
- Device Name
- Dental Root Canal Measuring and Treatment Units EUDAMED
- Model / Reference
- iRoot pro EUDAMEDSRCT2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971075370302 EUDAMED
- Basic UDI-DI
- B-06971075370302 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental delivery system
Dental Electrical Motors by ChangZhou BoMedent Medical Technology Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
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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 | K191276 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06971075370302 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ChangZhou BoMedent Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010413
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 44030f7a-3558-4d10-8c34-90519c2658ac 61 fields · synced Jul 8, 2026
- FDA 510(k) K191276 1 fields · synced May 18, 2026