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Dental Contra-angle Handpiece
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AC201L1Model W142L/W15L/W11L/W201L/AC142L/AC15L/AC201L
Identity
- Trade Name
- Dental Contra-angle Handpiece EUDAMEDDental High-speed Turbine Handpiece FDA UDI
- Generic Name
- Dental power tool system handpiece, pneumatic FDA UDI
- Device Name
- Dental Contra Angle Handpiece EUDAMEDThe Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector. The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only. Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). In order to avoid the risk, user must buy and use specified lubricant type “PANA SPRAY Plus” manufactured by NAKANISHI INC (cleared in K163483). FDA UDI
- Model / Reference
- W142L/W15L/W11L/W201L/AC142L/AC15L/AC201L EUDAMEDAC201L1 EUDAMEDT, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SUQP FDA UDI
- Description
- The Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector. The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only. Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). In order to avoid the risk, user must buy and use specified lubricant type “PANA SPRAY Plus” manufactured by NAKANISHI INC (cleared in K163483). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971119540012 EUDAMEDFDA UDI
- Basic UDI-DI
- 697111954CAHN7 EUDAMED
- Direct Marketing DI
- 06971119540012 EUDAMED
- 510(k) Number
- K170229 FDA UDI
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Dental power tool system handpiece, pneumatic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Poland EUDAMED
- 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Category: Dental delivery system
Dental Contra-angle Handpiece by Guangdong JINME Medical Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697111954CAHN7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Guangdong JINME Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000033806
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED db5d9135-be57-4fd2-bdff-8c2f0a59fa45 61 fields · synced Jun 19, 2026
- FDA UDI dc0abe19-c580-4498-9ba6-a28c614c353d 34 fields · synced May 30, 2026