Invisalign™ Ultrasonic Cleaning Station
Align Technology, Inc. · Model 218277 · UDI-DI 00816063022077
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."
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-31 | Ultra Clean Systems, Inc. | During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation. |
| 2024-08-23 | Young Dental Manufacturing I, LLC | The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination. |
| 2020-11-19 | Steris Corporation | STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the dete |
| 2020-06-26 | Steris Corporation | A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria. |
| 2007-07-03 | Pacific Bioscience Lab, Inc. | Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns. |
| 2006-06-22 | Steris Corporation | Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result i |
| 2006-06-22 | Steris Corporation | Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result i |
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