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PM PM 1:1 RO sp. ext. 104936

FDA UDI

Class I (US FDA UDI)

by Bien-Air Dental SA

Identity

Trade Name
PM PM 1:1 RO sp. ext. 104936 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. FDA UDI
Model / Reference
1601409-001 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. FDA UDI

Identifiers

Primary DI / UDI-DI
J00716014090011 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental power tool handpiece motorless component

PM PM 1:1 RO sp. ext. 104936 by Bien-Air Dental SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental power tool handpiece motorless component.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bien-Air Dental SA

Sources (1)

  • FDA UDI 61ccfb68-4287-4b46-8710-c12f0f8aaf3d 33 fields · synced Jun 8, 2026