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ultrapro Tx air

FDA UDI

Class I (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name
ultrapro Tx air FDA UDI
Generic Name
Dental delivery system instrument unit, pneumatic FDA UDI
Device Name
Ultrapro Tx Air Blue Nose Cone Kit FDA UDI
Model / Reference
8505- FDA UDI
Description
Ultrapro Tx Air Blue Nose Cone Kit FDA UDI

Identifiers

Catalog Number
8505- FDA UDI
Primary DI / UDI-DI
00883205028068 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Dental delivery system instrument unit, pneumatic 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

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental delivery system instrument unit, pneumatic

ultrapro Tx air by Ultradent Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental delivery system instrument unit, pneumatic.

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 782f9194-b915-4d6b-832f-92aca20b9829 35 fields · synced May 31, 2026