FDA.reportPublic FDA data

iTero Element™ 5D imaging system

Primary DI
00816063023029
Brand
iTero Element™ 5D imaging system
Company
Align Technology, Inc.
Model
217618
Device description
iTero Element™ 5D imaging system, Certified Pre-owned (US)
Published
2026-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NTKLight Transmission Caries Detector

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193659000iTero Element 5DAlign Technology, Inc.2020-03-20NTK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816063023029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816063023029008160630230298160630230290816063023029

GMDN Terms#

Term, Definition table
TermDefinition
Dental milling system, CAD/CAM, chairsideAn assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) 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.

Regulatory Flags#

DUNS number
013831768
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816063023791Cleaning Crystals, Packette2272872026-07-21
00816063022312iTero Lumina Pro DOA2219592026-06-25
00816063021735iTero Element 5D scanning unit, service2069552026-06-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816063022312iTero Lumina Pro DOAAlign Technology, Inc.NTK2026-06-25
00816063021735iTero Element 5D scanning unit, serviceAlign Technology, Inc.NTK2026-06-23
E27668082030Primescan 2SIRONA Dental Systems GmbHNTK2025-11-21
E27668082450Primescan 2SIRONA Dental Systems GmbHNTK2025-10-23
E27668053651Primescan 2 Multiuse SleeveSIRONA Dental Systems GmbHNTK2025-09-16
E27668558402Primescan 2SIRONA Dental Systems GmbHNTK2025-08-20
E27668020400Primescan 2SIRONA Dental Systems GmbHNTK2025-05-16
00816063023067iTero Lumina ProAlign Technology, Inc.NTK2025-03-06
04262352350035DI ScanZetta25 AGNTK2025-02-21
10194665007928A-dec A-DEC, INC.NTK2025-02-11
EKAV101537000DIAGNOcam Vision Full HDKaVo Dental GmbHNTK2024-12-03
00816063022213iTero Lumina ProAlign Technology, Inc.NTK2024-11-19
00816063022237iTero Lumina Pro MobileAlign Technology, Inc.NTK2024-11-19
00816063022268iTero Lumina Pro intraoral scanning unitAlign Technology, Inc.NTK2024-11-19
00816063022329iTero Lumina Pro DOAAlign Technology, Inc.NTK2024-11-19
00816063022428iTero Lumina Pro UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022442iTero Lumina Pro Mobile UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022466iTero Lumina Pro UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022589iTero Lumina Pro Wand Barrier SleevesAlign Technology, Inc.NTK2024-11-19
00816063022657iTero Lumina ProAlign Technology, Inc.NTK2024-11-19
00816063022664iTero Lumina ProAlign Technology, Inc.NTK2024-11-19
EKAV101112130DIAGNOcam Vision Full HDKaVo Dental GmbHNTK2024-02-01
EKAV101315000DIAGNOcam Vision Full HDKaVo Dental GmbHNTK2024-02-01
00858809006224Planmeca Emerald SD4D TECHNOLOGIES, LLCNTK2022-07-06
EKAV100270000DIAGNOdent pen 2190KaVo Dental GmbHNTK2022-04-15
E247J27131CamX Proxi Interchangeable HeadDÜRR DENTAL SENTK2022-03-04
00816063020691iTero Element 5D Plus cart configuration Align Technology, Inc.NTK2021-06-04
00816063020707iTero Element 5D Plus US cart configurationAlign Technology, Inc.NTK2021-06-04
00816063020721iTero Element 5D Plus upgrade cart configurationAlign Technology, Inc.NTK2021-06-04
00816063020745iTero Element 5D Plus mobile configurationAlign Technology, Inc.NTK2021-06-04