Avex CX

FDA UDI

Class I (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name: Avex CX FDA UDI
Generic Name: Orthodontic bracket, ceramic FDA UDI
Device Name: Avex CX .018 UR2 (+10°T 8°A) FDA UDI
Model / Reference: 214006 FDA UDI
Description: Avex CX .018 UR2 (+10°T 8°A) FDA UDI

Identifiers

Catalog Number: 214006 FDA UDI
Primary DI / UDI-DI: 00883205108265 FDA UDI
FDA Product Code: EJF FDA UDI
GMDN Term: Orthodontic bracket, ceramic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.5410 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: Orthodontic bracket, ceramic

Avex CX by Ultradent Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Experience — GC Orthodontics America Inc. · Class II
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APC™ II Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
EXPERIENCE® — GC Orthodontics America Inc. · Class II
APC™ PLUS Clarity™ SL — 3M UNITEK CORPORATION · Class II

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 f99a22e2-7ef3-4547-a916-3d3f85b4c436 36 fields · synced May 31, 2026