Invisalign UV Sanitizing Case

FDA UDI

Class I (US FDA UDI)

by Align Technology, Inc.

Identity

Trade Name: Invisalign UV Sanitizing Case FDA UDI
Generic Name: Orthodontic appliance automated cleaner FDA UDI
Device Name: The Invisalign UV Sanitizing Case is a portable, over-the-counter device that is intended to sanitize Invisalign clear aligners. FDA UDI
Model / Reference: 214150 FDA UDI
Description: The Invisalign UV Sanitizing Case is a portable, over-the-counter device that is intended to sanitize Invisalign clear aligners. FDA UDI

Identifiers

Primary DI / UDI-DI: 00816063021896 FDA UDI
FDA Product Code: NOB FDA UDI
GMDN Term: Orthodontic appliance automated cleaner FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6855 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

Yes

FDA UDI

Convenience Kit

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Combination Product

FDA UDI

HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

Yes

FDA UDI

Category: Orthodontic appliance automated cleaner

Invisalign UV Sanitizing Case by Align Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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SmileSet QX105 Ultrasonic Cleaner - Black — ORTHO DENTAL LAB, LLC · Class I
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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: Align Technology, Inc.

Sources (1)

FDA UDI d6c2b032-19fc-4a49-9233-9edfcd33fa74 33 fields · synced May 31, 2026