FDA.reportPublic FDA data

Invisalign UV Sanitizing Case

Primary DI
00816063021896
Brand
Invisalign UV Sanitizing Case
Company
Align Technology, Inc.
Model
214150
Device description
The Invisalign UV Sanitizing Case is a portable, over-the-counter device that is intended to sanitize Invisalign clear aligners.
Published
2023-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NOBUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOBUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-SterileDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816063021896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816063021896008160630218968160630218960816063021896

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816063022169Attachment Template1000122023-07-24
00816063023180Invisalign ART90502026-02-25
00816063023777Invisalign Specifix Attachment System50352026-02-09
00816063023784lnvisalign Specifix Attachment System (include Engagement Features)50362026-02-09
00816063023760Gumlines2267972026-01-01
00816063023173iTero Lumina – PC cfg, Interface Box2176222025-09-16
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
00816063022077Invisalign™ Ultrasonic Cleaning Station2182772023-07-25
00816063021407Cleaning Crystals, Packette201272022-12-06
00816063021360ClinCheckSW-00001592022-02-17
00816063020233NuMe90052017-06-02
00816063020004Invisalign Full85002016-09-24
00816063020011Invisalign10112016-09-24
00816063020035Invisalign Teen85062016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078989017SmileSet QX105 Ultrasonic Cleaner - BlackOrtho Dental Lab LLCNOB2025-09-17
00850078989031SmileSet QX105 Ultrasonic Cleaner - MintOrtho Dental Lab LLCNOB2025-09-17
00850078989048SmileSet QX105 Ultrasonic Cleaner - WhiteOrtho Dental Lab LLCNOB2025-09-17
00850078989055SmileSet Rechargeable Ultrasonic Cleaner - BlackOrtho Dental Lab LLCNOB2025-09-17
00850078989062Smileset Rechargeable Ultrasonic Cleaner – MintOrtho Dental Lab LLCNOB2025-09-17
00850078989079Smileset Rechargeable Ultrasonic Cleaner – WhiteOrtho Dental Lab LLCNOB2025-09-17
00850017524224Portable UV SanitizerSTRAIGHT SMILE LLCNOB2023-03-20
00840326408230The Orthodontic StoreYoung Innovations, Inc.NOB2022-11-24
00075020095770Philips SonicarePHILIPS ORAL HEALTHCARE, LLCNOB2020-09-24