Identity
- Trade Name
- TU Bora 2 LK EUDAMEDFDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
- Device Name
- Turbines EUDAMEDTurbine type high- speed handpiece. Unit supplied by a hose, via a special ISO 9168 coupling. Anti- heat push- button bur changing mechanism. Ceramic ball bearings, 4 sprays. Optical glass rod with light. FDA UDI
- Model / Reference
- Turbines EUDAMED1601153-001 EUDAMEDFDA UDI
- Description
- Turbine type high- speed handpiece. Unit supplied by a hose, via a special ISO 9168 coupling. Anti- heat push- button bur changing mechanism. Ceramic ball bearings, 4 sprays. Optical glass rod with light. FDA UDI
Identifiers
- Catalog Number
- 1601153-001 FDA UDI
- Primary DI / UDI-DI
- J00716011530011 EUDAMEDFDA UDI
- Basic UDI-DI
- ++J007TURB00014S EUDAMED
- Direct Marketing DI
- J00716011530011 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
TU Bora 2 LK 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 2f1586d4-c22c-4be7-84fc-fbbf99920039 61 fields · synced Jun 18, 2026
- FDA UDI d439cd80-446d-439a-8c7e-3d26dd2061b8 35 fields · synced May 30, 2026