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Console iOptima INT MX2 MX-i
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1601076-001Model INTEGRABLE DEVICES
Identity
- Trade Name
- Console iOptima INT MX2 MX-i EUDAMEDFDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- INTEGRABLE DEVICES EUDAMEDiOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad). FDA UDI
- Model / Reference
- INTEGRABLE DEVICES EUDAMED1601076-001 EUDAMEDFDA UDI
- Description
- iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad). FDA UDI
Identifiers
- Catalog Number
- 1601076-001 FDA UDI
- Primary DI / UDI-DI
- J00716010760011 EUDAMEDFDA UDI
- Basic UDI-DI
- ++J007IOPT0001YC EUDAMED
- Direct Marketing DI
- J00716010760011 EUDAMED
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER EUDAMED
- GMDN Term
- Surgical power tool system control unit, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6640 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
Console iOptima INT MX2 MX-i 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 | ++J007IOPT0001YC | 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 49af9feb-795f-4fcf-a9f3-dc7ee0ee934e 61 fields · synced Jun 18, 2026
- FDA UDI 2e06e9ff-078b-470b-a02e-64ce46587fb4 35 fields · synced May 30, 2026