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Tur Bora + Unfix 4H

FDA UDI

Class I (US FDA UDI)

by Bien-Air Dental SA

Identity

Trade Name
Tur Bora + Unfix 4H FDA UDI
Generic Name
Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
Device Name
Turbines are intended to generate rotating mechanical energy from compressed air FDA UDI
Model / Reference
1700188-001 FDA UDI
Description
Turbines are intended to generate rotating mechanical energy from compressed air FDA UDI

Identifiers

Catalog Number
1700188-001 FDA UDI
Primary DI / UDI-DI
J00717001880011 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Dental surgical power tool motorized handpiece/set, 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

No

FDA UDI

Category: Dental surgical power tool motorized handpiece/set, pneumatic

Tur Bora + Unfix 4H by Bien-Air Dental SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental surgical power tool motorized handpiece/set, pneumatic.

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 d53b32ac-69d9-46a8-8f2a-bdcf2c25be17 35 fields · synced Jun 1, 2026