FDA.reportPublic FDA data

iTero Element 5D US System

Primary DI
00816063020639
Brand
iTero Element 5D US System
Company
Align Technology, Inc.
Model
209156
Device description
Scanner
Published
2020-06-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

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
00816063020639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816063020639008160630206398160630206390816063020639

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
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
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
00816063020752iTero Element 5D Plus US mobile configurationAlign Technology, Inc.NTK2021-06-04
00816063020776iTero Element 5D Plus upgrade mobile configurationAlign Technology, Inc.NTK2021-06-04