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Tur Black Pearl ECO 4H
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1600040-001Model Turbines
Identity
- Trade Name
- Tur Black Pearl ECO 4H EUDAMEDFDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
- Device Name
- Turbines EUDAMEDTurbines are intended to generate rotating mechanical energy from compressed air FDA UDI
- Model / Reference
- Turbines EUDAMED1600040-001 EUDAMEDFDA UDI
- Description
- Turbines are intended to generate rotating mechanical energy from compressed air FDA UDI
Identifiers
- Catalog Number
- 1600040-001 FDA UDI
- Primary DI / UDI-DI
- J00716000400011 EUDAMEDFDA UDI
- Basic UDI-DI
- ++J007TURB00014S EUDAMED
- Direct Marketing DI
- J00716000400011 EUDAMED
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER EUDAMED
- GMDN Term
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Austria 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Tur Black Pearl ECO 4H by Bien-Air Dental SA — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | ++J007TURB00014S | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bien-Air Dental SA
- EUDAMED SRN
- CH-MF-000014661
- Authorised Representative
- Bien-Air Europe Sàrl FR-AR-000011942
Sources (2)
- EUDAMED b8241296-e9dd-417c-b4e1-bf95612ae550 61 fields · synced Oct 6, 2026
- FDA UDI 2e1b9d23-29a9-4058-a084-4a2932f859ab 35 fields · synced May 30, 2026