FDA.reportPublic FDA data

iTero Lumina Pro

Primary DI
00816063022213
Brand
iTero Lumina Pro
Company
Align Technology, Inc.
Model
221951
Device description
iTero Lumina Pro US Cart Configuration
Published
2024-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NTKCaries Detector, Laser Light, Transmission
QJKIntraoral Camera

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTKCaries Detector, Laser Light, TransmissionDental2
QJKIntraoral CameraDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240573000iTero Lumina™ ProAlign Technology , Ltd.2024-08-16NTK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816063022213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816063022213008160630222138160630222130816063022213

GMDN Terms#

Term, Definition table
TermDefinition
Intraoral optical scanning systemAn assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013831768
Device count
1
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
E27668082030Primescan 2SIRONA Dental Systems GmbHNTK2025-11-21
E27668082450Primescan 2SIRONA Dental Systems GmbHNTK2025-10-23
06971119542399Intra Oral CameraGuangdong JINME Medical Technology Co., Ltd.QJK2025-09-18
06971119542405Intra Oral CameraGuangdong JINME Medical Technology Co., Ltd.QJK2025-09-18
E27668053651Primescan 2 Multiuse SleeveSIRONA Dental Systems GmbHNTK2025-09-16
E27668558402Primescan 2SIRONA Dental Systems GmbHNTK2025-08-20
06971119540968Intra Oral ScannerGuangdong JINME Medical Technology Co., Ltd.QJK2025-07-15
06971119540975Intra Oral ScannerGuangdong JINME Medical Technology Co., Ltd.QJK2025-07-15
06971119542382Intra Oral CameraGuangdong JINME Medical Technology Co., Ltd.QJK2025-07-15
E27668020400Primescan 2SIRONA Dental Systems GmbHNTK2025-05-16
00816063023067iTero Lumina ProAlign Technology, Inc.NTK2025-03-06
00816063023067iTero Lumina ProAlign Technology, Inc.QJK2025-03-06
04262352350035DI ScanZetta25 AGNTK2025-02-21
10194665007928A-dec A-DEC, INC.NTK2025-02-11
EKAV101537000DIAGNOcam Vision Full HDKaVo Dental GmbHNTK2024-12-03
00816063022237iTero Lumina Pro MobileAlign Technology, Inc.NTK2024-11-19
00816063022237iTero Lumina Pro MobileAlign Technology, Inc.QJK2024-11-19
00816063022268iTero Lumina Pro intraoral scanning unitAlign Technology, Inc.NTK2024-11-19
00816063022268iTero Lumina Pro intraoral scanning unitAlign Technology, Inc.QJK2024-11-19
00816063022329iTero Lumina Pro DOAAlign Technology, Inc.NTK2024-11-19
00816063022329iTero Lumina Pro DOAAlign Technology, Inc.QJK2024-11-19
00816063022428iTero Lumina Pro UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022428iTero Lumina Pro UpgradeAlign Technology, Inc.QJK2024-11-19
00816063022442iTero Lumina Pro Mobile UpgradeAlign Technology, Inc.QJK2024-11-19
00816063022442iTero Lumina Pro Mobile UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022466iTero Lumina Pro UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022466iTero Lumina Pro UpgradeAlign Technology, Inc.QJK2024-11-19
00816063022589iTero Lumina Pro Wand Barrier SleevesAlign Technology, Inc.NTK2024-11-19
00816063022589iTero Lumina Pro Wand Barrier SleevesAlign Technology, Inc.QJK2024-11-19
00816063022657iTero Lumina ProAlign Technology, Inc.NTK2024-11-19