A-dec

FDA UDI

Class I (US FDA UDI)

by A-Dec, Inc.

Identity

Trade Name: A-dec FDA UDI
Generic Name: Dental surgical power tool motor, electric FDA UDI
Device Name: NSK NLZ BA,Control Module FDA UDI
Model / Reference: 54.0437.00 FDA UDI
Description: NSK NLZ BA,Control Module FDA UDI

Identifiers

Catalog Number: 54.0437.00 FDA UDI
Primary DI / UDI-DI: 10194665006150 FDA UDI
FDA Product Code: EBW FDA UDI
GMDN Term: Dental surgical power tool motor, electric 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

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

Yes

FDA UDI

Category: Dental surgical power tool motor, electric

A-dec by A-Dec, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: A-Dec, Inc.

Sources (1)

FDA UDI 510e15c0-bbf7-4828-bc7e-463c0ea209cc 34 fields · synced May 30, 2026