UltraTect

FDA UDI

Class I (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name: UltraTect FDA UDI
Generic Name: Eye splash shield, single-use FDA UDI
Device Name: Black and Orange Frame/Brown Lens FDA UDI
Model / Reference: 914- FDA UDI
Description: Black and Orange Frame/Brown Lens FDA UDI

Identifiers

Catalog Number: 914- FDA UDI
Primary DI / UDI-DI: 00883205019721 FDA UDI
FDA Product Code: LYU FDA UDI
GMDN Term: Eye splash shield, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4040 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Eye splash shield, single-use

UltraTect by Ultradent Products, 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: Ultradent Products, Inc.

Sources (1)

FDA UDI ae9e51dd-9b0f-4d77-81cc-97bd41b31ec1 35 fields · synced May 30, 2026