Invisalign™ Ultrasonic Cleaning Station

Primary DI
00816063022077
Brand
Invisalign™ Ultrasonic Cleaning Station
Company
Align Technology, Inc.
Model
218277
Device 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."""
Published
2023-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FLGCleaner, Ultrasonic, Medical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816063022077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816063022077008160630220778160630220770816063022077

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance automated cleanerAn electromechanical device designed to clean soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. The orthodontic appliances are typically placed in a receptacle and water together with an appropriate cleansing tablet or solution, and cleaned through an automated cycle. An audible signal may alert the user that the program has finished.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013831768
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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00816063023777Invisalign Specifix Attachment System50352026-02-09
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00816063023197iTero Lumina Software2259692025-09-16
00816063023210iTero Lumina – PC cfg2231122025-09-16
00816063023227iTero Lumina – PC cfg2231102025-09-16
00816063023241iTero Lumina – PC cfg2231112025-09-16
00816063023289iTero Lumina – PC cfg2231662025-09-16
00816063023296iTero Lumina – PC cfg2231142025-09-16
00816063021377Invisalign Go Express90332025-09-15
00816063021407Cleaning Crystals, Packette201272022-12-06
00816063021360ClinCheckSW-00001592022-02-17
00816063020233NuMe90052017-06-02
00816063020004Invisalign Full85002016-09-24
00816063020011Invisalign10112016-09-24
00816063020035Invisalign Teen85062016-09-24
00816063020110Vivera85792016-09-24

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