Invisalign™ Ultrasonic Cleaning Station

GUDID 00816063022077

"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."

Align Technology, Inc.

Orthodontic appliance automated cleaner

• Primary Device ID: 00816063022077
• NIH Device Record Key: fca8e419-e0f3-417f-a328-e54e8d11ce87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisalign™ Ultrasonic Cleaning Station
• Version Model Number: 218277
• Company DUNS: 013831768
• Company Name: Align Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816063022077 [Primary]

FDA Product Code

• FLG: Cleaner, Ultrasonic, Medical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-02
• Device Publish Date: 2023-07-25

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