Identity
- Trade Name
- PM 1:1 TWIST DRILL FDA UDI
- Generic Name
- Dental power tool handpiece motorless component FDA UDI
- Device Name
- Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor. Product intended for use in oral and maxillofacial surgery. FDA UDI
- Model / Reference
- 1601190-001 FDA UDI
- Description
- Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor. Product intended for use in oral and maxillofacial surgery. FDA UDI
Identifiers
- Catalog Number
- 1601190-001 FDA UDI
- Primary DI / UDI-DI
- J00716011900011 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental power tool handpiece motorless component 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental power tool handpiece motorless component
Pm 1:1 Twist Drill by Bien-Air Dental SA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bien-Air Dental SA
Sources (2)
- FDA UDI 88f55f38-337a-44e9-9c24-afa1d58e69cf 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026