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Wireless Footctrl + Dongle

FDA UDI

Class I (US FDA UDI)

by Bien-Air Dental SA

Identity

Trade Name
WIRELESS FOOTCTRL + DONGLE FDA UDI
Generic Name
Foot-switch, electrical FDA UDI
Device Name
Used to controle the console used in dentistry for implantology, dental surgery and endodontic work. FDA UDI
Model / Reference
1601192-001 FDA UDI
Description
Used to controle the console used in dentistry for implantology, dental surgery and endodontic work. FDA UDI

Identifiers

Catalog Number
1601192-001 FDA UDI
Primary DI / UDI-DI
J00716011920011 FDA UDI
FDA Product Code
EBW FDA UDI
GMDN Term
Foot-switch, electrical 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

Category: Foot-switch, electricalSurgical power tool system control unit, line-powered

Wireless Footctrl + Dongle by Bien-Air Dental SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical power tool system control unit, line-powered.

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 fbb47d86-4adc-425c-952a-149d0fb27587 35 fields · synced Jun 8, 2026