Coupling Unifix 4H

FDA UDI

Class I (US FDA UDI)

by Bien-Air Portugal, Unipessoal, Lda

Identity

Trade Name: Coupling Unifix 4H FDA UDI
Generic Name: Pneumatic dental handpiece coupler FDA UDI
Device Name: Hoses and couplings are essential accessories meant to connect micro-motors to the console or other boards, thus allowing the control and functioning of the whole device. FDA UDI
Model / Reference: 1600082-001 FDA UDI
Description: Hoses and couplings are essential accessories meant to connect micro-motors to the console or other boards, thus allowing the control and functioning of the whole device. FDA UDI

Identifiers

Catalog Number: 1600082-001 FDA UDI
Primary DI / UDI-DI: J00716000820011 FDA UDI
FDA Product Code: EFB FDA UDI
GMDN Term: Pneumatic dental handpiece coupler 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Pneumatic dental handpiece coupler

Coupling Unifix 4H by Bien-Air Portugal, Unipessoal, Lda — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Airlight — Beyes Dental Canada Inc · Class I
DENTALAIRE — Beyes Dental Canada Inc · 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 Portugal, Unipessoal, Lda

Sources (1)

FDA UDI dbc725bf-198c-442a-b5ce-dd38d3559598 35 fields · synced Jun 8, 2026