Identity
- Trade Name
- SET iCHIROPRO EUDAMEDFDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- iCHIROPRO EUDAMEDSets of iChiropro systems and their dental micromotors or contra-angles plus relevant accessories FDA UDI
- Model / Reference
- iCHIROPRO EUDAMED1700439-001 EUDAMEDFDA UDI
- Description
- Sets of iChiropro systems and their dental micromotors or contra-angles plus relevant accessories FDA UDI
Identifiers
- Catalog Number
- 1700439-001 FDA UDI
- Primary DI / UDI-DI
- J00717004390011 EUDAMEDFDA UDI
- Basic UDI-DI
- ++J007ICHI0001JX EUDAMED
- Direct Marketing DI
- J00717004390011 EUDAMED
- FDA Product Code
- EBW FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Surgical power tool system control unit, line-powered 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
Yes
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
Category: Dental delivery system
SET iCHIROPRO by Bien-Air Dental SA — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | ++J007ICHI0001JX | 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 8ae11b8c-9c9e-44de-8699-a966be5e5dcf 61 fields · synced May 30, 2026
- FDA UDI 3337dd28-fb6f-41df-a6d5-a1386d3f8822 35 fields · synced May 30, 2026