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Board DMX2 Plus

FDA UDI

Class I (US FDA UDI)

by Bien-Air Dental SA

Identity

Trade Name
Board DMX2 Plus FDA UDI
Generic Name
Surgical power tool system control unit, line-powered FDA UDI
Device Name
Boards are essential accessories meant to drive electrical micro-motors FDA UDI
Model / Reference
1600696-001 FDA UDI
Description
Boards are essential accessories meant to drive electrical micro-motors FDA UDI

Identifiers

Catalog Number
1600696-001 FDA UDI
Primary DI / UDI-DI
J00716006960011 FDA UDI
FDA Product Code
EIA FDA UDI
GMDN Term
Surgical power tool system control unit, line-powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 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: Surgical power tool system control unit, line-powered

Board DMX2 Plus 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 e0fc88b1-b77f-43bd-a8aa-346187bac6e6 35 fields · synced May 31, 2026