Identity
- Trade Name
- Set Aquilon830 IR NC + Unifix 3H FDA UDI
- Generic Name
- Dental power tool system handpiece, pneumatic FDA UDI
- Device Name
- Set of micromotor and Accessory connects micro-motors to the console FDA UDI
- Model / Reference
- 1700058-001 FDA UDI
- Description
- Set of micromotor and Accessory connects micro-motors to the console FDA UDI
Identifiers
- Catalog Number
- 1700058-001 FDA UDI
- Primary DI / UDI-DI
- J00717000580011 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental power tool system handpiece, pneumatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
Yes
FDA UDI
Category: Dental power tool system handpiece, pneumatic
Set Aquilon830 IR NC + Unifix 3H by Bien-Air Dental SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental power tool system handpiece, pneumatic.
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- MK-dent Germany® — MK-Dent GmbH · Class I
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 133dae43-5728-4018-9e36-55c130d571d1 35 fields · synced May 30, 2026