Nlz

FDA UDI

Class I (US FDA UDI)

by Nakanishi Inc.

Identity

Trade Name: NLZ FDA UDI
Generic Name: Dental surgical power tool motor, electric FDA UDI
Model / Reference: NLZ BF FDA UDI

Identifiers

Primary DI / UDI-DI: 04589551381500 FDA UDI
510(k) Number: K233288 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

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

Yes

FDA UDI

Category: Surgical power tool system control unit, line-powered Dental surgical power tool motor, electric

Nlz by Nakanishi Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental surgical power tool motor, electric.

Ultrapro TX Cordless — ULTRADENT PRODUCTS, INC. · Class I
Aseptico — ASEPTICO, INC. · Class I
A-dec — A-Dec, Inc. · Class I
Aseptico — ASEPTICO, INC. · Class I
Brasseler USA — Peter Brasseler Holdings, LLC · Class I
Glidewell Laboratory — ASEPTICO, INC. · Class I
Ultrapro TX Cordless — ULTRADENT PRODUCTS, INC. · Class I
Aseptico — ASEPTICO, INC. · Class I

Cleared under the same submission

K233288 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Nakanishi Inc.

Sources (1)

FDA UDI 16a3cdb6-6f96-4b51-a9ce-5dca0822ae6f 33 fields · synced May 30, 2026