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Invisalign™ Ultrasonic Cleaning Station

FDA UDI

Class I (US FDA UDI)

by Align Technology, Inc.

Identity

Trade Name
Invisalign™ Ultrasonic Cleaning Station FDA UDI
Generic Name
Orthodontic appliance automated cleaner FDA UDI
Device Name
"The Invisalign Ultrasonic Cleaning Station is an over-the-counter electronic appliance that is intended to clean Invisalign® System clear aligner orthodontic appliances and Invisalign® and Vivera™ retainers using ultrasonic vibrations. The Invisalign™ Ultrasonic Cleaning Station is a countertop device that cleans Invisalign® clear aligners and Invisalign® and Vivera™ retainers by transmitting high-frequency sound waves (also called ‘ultrasonic’ vibrations) through a liquid medium, creating microscopic “scrubbing/ scouring” bubbles which dislodge debris as they collapse. The device offers a convenient way to clean these removable orthodontic appliances at home in as little as five minutes using just plain tap water and with no additional chemicals. In testing with water, the Invisalign Ultrasonic Cleaning Station removed 98.3% to 99.9% of the following odor-causing bacteria from Invisalign® clear aligners: Pseudomonas aeruginosa, Staphylococcus aureus, Klebsiella pneumoniae, Enterobacter cloacae and Escherichia coli. Performance of bacteria removal for retainers has not been evaluated." FDA UDI
Model / Reference
218277 FDA UDI
Description
"The Invisalign Ultrasonic Cleaning Station is an over-the-counter electronic appliance that is intended to clean Invisalign® System clear aligner orthodontic appliances and Invisalign® and Vivera™ retainers using ultrasonic vibrations. The Invisalign™ Ultrasonic Cleaning Station is a countertop device that cleans Invisalign® clear aligners and Invisalign® and Vivera™ retainers by transmitting high-frequency sound waves (also called ‘ultrasonic’ vibrations) through a liquid medium, creating microscopic “scrubbing/ scouring” bubbles which dislodge debris as they collapse. The device offers a convenient way to clean these removable orthodontic appliances at home in as little as five minutes using just plain tap water and with no additional chemicals. In testing with water, the Invisalign Ultrasonic Cleaning Station removed 98.3% to 99.9% of the following odor-causing bacteria from Invisalign® clear aligners: Pseudomonas aeruginosa, Staphylococcus aureus, Klebsiella pneumoniae, Enterobacter cloacae and Escherichia coli. Performance of bacteria removal for retainers has not been evaluated." FDA UDI

Identifiers

Primary DI / UDI-DI
00816063022077 FDA UDI
FDA Product Code
FLG FDA UDI
GMDN Term
Orthodontic appliance automated cleaner FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6150 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic appliance automated cleaner

Invisalign™ Ultrasonic Cleaning Station by Align Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic appliance automated cleaner.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Align Technology, Inc.

Sources (1)

  • FDA UDI fca8e419-e0f3-417f-a328-e54e8d11ce87 33 fields · synced May 30, 2026