Identity
- Trade Name
- CONSOLE OPTIMA MX2 INT DMX3 CL FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- Optima consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connected to a dental pneumatic unit FDA UDI
- Model / Reference
- 1700788-001 FDA UDI
- Description
- Optima consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connected to a dental pneumatic unit FDA UDI
Identifiers
- Catalog Number
- 1700788-001 FDA UDI
- Primary DI / UDI-DI
- J00717007880011 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Surgical power tool system control unit, line-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Surgical power tool system control unit, line-powered
Console Optima Mx2 Int Dmx3 Cl by Bien-Air Dental SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bien-Air Dental SA
Sources (1)
- FDA UDI 9e77a43b-4dbc-4699-86d5-0b28c7dc0a9b 35 fields · synced May 31, 2026