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Ultrapro TX Cordless

FDA UDI

Class I (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 Wall Charger Replacement Part FDA UDI
Model / Reference
5531- FDA UDI
Description
Ultrapro Tx Cordless Prophy Wall Charger Replacement Part FDA UDI

Identifiers

Catalog Number
5531- FDA UDI
Primary DI / UDI-DI
00883205035394 FDA UDI
510(k) Number
K211531 FDA UDI
FDA Product Code
EKX 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental surgical power tool motor, electric

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

Similar devices

Also classified as Dental surgical power tool motor, electric.

Cleared under the same submission

K211531 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ultradent Products, Inc.

Sources (1)

  • FDA UDI d2c2eae9-b9d4-4dcb-bff7-977ce5985cd6 36 fields · synced May 30, 2026