FDA.reportPublic FDA data

iTero Articulator Kit

Primary DI
00816063020677
Brand
iTero Articulator Kit
Company
Align Technology, Inc.
Model
107806
Device description
Scanner
Published
2021-06-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EJPArticulators

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJPArticulatorsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816063020677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816063020677008160630206778160630206770816063020677

GMDN Terms#

Term, Definition table
TermDefinition
Dental CAD/CAM system, chairsideAn assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (specifically prescribed to each patient's needs) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for the production of the actual devices to be fitted to the patient.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013831768
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
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
D040342160MA2340 W/STRAPSWHIP-MIX CORPORATIONEJP2025-09-11
00348783005813W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005820W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005837W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005844W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005851W.O.W.™ 2PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
D040200113770Denar Mark 310 ArticulatorWHIP-MIX CORPORATIONEJP2024-02-27
D040200113780Denar Mark 320 ArticulatorWHIP-MIX CORPORATIONEJP2024-02-27
D040200114080Denar Mark 330 ArticulatorWHIP-MIX CORPORATIONEJP2024-02-27
08800075601490OSUNG MNDOSUNG MND Co., Ltd.EJP2024-02-22
08964003163570Doctor NiceB. Ali ImpexEJP2024-01-29
08964003163587ECCOB. Ali ImpexEJP2024-01-29
E1997592331ArticulatorCandulor AGEJP2023-10-18
E23550700HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550710HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550730HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550740HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550750HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550760HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
D0400033020001Hanau 96 H2 ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400098560001Hanau-Mate Non-Adjustable ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400108850001Hanau Wide-Vue ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400141020001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400141160001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400143000001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400143090001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400145030001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400224614640 Q ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400226712240 ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400227814641 ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22