EZ-Align

FDA UDI

Class II (US FDA UDI)

by Ortho Solutions LC

Identity

Trade Name: EZ-Align FDA UDI
Generic Name: Orthodontic progressive aligner FDA UDI
Device Name: Clear Sequential Aligner System FDA UDI
Model / Reference: 0091 FDA UDI
Description: Clear Sequential Aligner System FDA UDI

Identifiers

Catalog Number: 0091 FDA UDI
Primary DI / UDI-DI: D84100911Z FDA UDI
510(k) Number: K121396 FDA UDI
FDA Product Code: NXC FDA UDI
GMDN Term: Orthodontic progressive aligner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5470 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Orthodontic progressive aligner

EZ-Align by Ortho Solutions LC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic progressive aligner.

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Reveal® Aligners — Ortho Organizers, Inc. · Class II
SLX® Clear Aligners — Ortho Organizers, Inc. · Class II
Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
3M™ Clarity™ — 3M UNITEK CORPORATION · Class II
Risas Reveal Aligners — Ortho Organizers, Inc. · Class II
Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II

Cleared under the same submission

K121396 also covers:

EZ-Align — Ortho Solutions LC

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: Ortho Solutions LC

Sources (1)

FDA UDI c1a2bc0c-d07b-4744-8d40-4d7cdb7e1c4d 35 fields · synced May 31, 2026