Ultrapro TX Cordless

FDA UDI

Class II (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name: Ultrapro TX Cordless FDA UDI
Generic Name: Dental surgical power tool motor, electric FDA UDI
Device Name: Ultrapro Tx Cordless Prophy Motor Barrier Sleeves 500 ct FDA UDI
Model / Reference: 5499 FDA UDI
Description: Ultrapro Tx Cordless Prophy Motor Barrier Sleeves 500 ct FDA UDI

Identifiers

Catalog Number: 5499 FDA UDI
Primary DI / UDI-DI: 00815967025924 FDA UDI
510(k) Number: K151123 FDA UDI
FDA Product Code: PEM FDA UDI
GMDN Term: Dental surgical power tool motor, electric FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental surgical power tool motor, electric

Ultrapro TX Cordless by Ultradent Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K151123 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 II	Pending data

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Manufacturer

Manufacturer: Ultradent Products, Inc.

Sources (1)

FDA UDI da3ce244-dc9a-47eb-bcd7-5288ac563c95 36 fields · synced May 30, 2026