Invisalign System with Mandibular advancement - enhanced precision wings

FDA UDI

Class II (US FDA UDI)

by Align Technology, Inc.

Identity

Trade Name: Invisalign System with Mandibular advancement - enhanced precision wings FDA UDI
Generic Name: Orthodontic progressive aligner FDA UDI
Device Name: The Invisalign System with Mandibular advancement - enhanced precision wings (EPW) is used to treat patients with Class I and Class II malocclusion, severe open bit, severe overjet, deep bit, skeletally narrow jaw, and dental prostheses/implants, and/or those who require surgical correction. The EPW are modified precision wings with longer and curved wings, with an added rib on buccal side, which are designed to optimize mandibular advancement. FDA UDI
Model / Reference: 222715 FDA UDI
Description: The Invisalign System with Mandibular advancement - enhanced precision wings (EPW) is used to treat patients with Class I and Class II malocclusion, severe open bit, severe overjet, deep bit, skeletally narrow jaw, and dental prostheses/implants, and/or those who require surgical correction. The EPW are modified precision wings with longer and curved wings, with an added rib on buccal side, which are designed to optimize mandibular advancement. FDA UDI

Identifiers

Primary DI / UDI-DI: 00816063022145 FDA UDI
510(k) Number: K181739 FDA UDI
K220287 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

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

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Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic progressive aligner

Invisalign System with Mandibular advancement - enhanced precision wings by Align Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K181739 also covers:

K220287 also covers:

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: Align Technology, Inc.

Sources (1)

FDA UDI acda1cdd-23b3-4cea-af4f-0183461c2927 34 fields · synced Jun 8, 2026