iTero — Element 5D & Lumina Intraoral Scanners

iTero is the intraoral scanner brand owned by Align Technology, Inc., best known consumer-side as the maker of Invisalign clear aligners. This page is a neutral manufacturer profile — parent company, manufacturing origin, the two current scanner models (Element 5D Plus and Lumina), FDA 510(k) status, cloud storage, and the competitive claims Align/iTero themselves publish. All facts on this page are sourced from Align's own documentation and the U.S. FDA's public 510(k) database.

About iTero / Align Technology

Align Technology was founded in 1997 and pioneered the clear-aligner orthodontic category with Invisalign. The iTero intraoral scanner line entered Align via the April 2011 acquisition of Cadent Holdings, an Israeli digital impression company. Per FDA 510(k) filings, the most recent iTero scanner (Lumina Pro) is listed as manufactured by Align Technology, Ltd., Align's Israeli subsidiary — continuing the Cadent / Israel R&D and manufacturing lineage.

Unlike most other intraoral scanner makers, iTero is part of a publicly traded company with a deeply integrated software ecosystem: Align ClinCheck, Invisalign Doctor Site, and the Align Oral Health Suite all consume iTero scans directly.

Product Timeline

• 2011Align acquires Cadent, bringing the iTero intraoral scanner platform into the Align portfolio.
• 2017iTero Element launched as the first all-in-one cart scanner under Align ownership.
• 2019iTero Element 5D introduced — adds NIRI (Near-Infrared Imaging) caries detection to the 3D scan + color photo workflow.
• 2020iTero Element 5D — FDA 510(k) clearance K193659 (Mar 20, 2020) under product code NTK (laser caries-detection feature).
• 2024iTero Lumina launched — new generation with redesigned wide field-of-view wand. 510(k) K240573 (Lumina Pro) cleared Aug 16, 2024.

Current Intraoral Scanner Lineup (2026)

Per the user's scope, this page covers Align's two currently-positioned flagship iTero scanners. Both feed into the same Align ClinCheck / Invisalign / Align Oral Health Suite ecosystem.

iTero Lumina

Flagship · Wide field-of-view

Align's current flagship intraoral scanner, introduced in 2024. Marketed by iTero as having a 3× larger field of view and a 50% smaller wand versus the prior Element generation, with 2× faster scans. Includes the Align Oral Health Suite with photorealistic scans and full integration into the Invisalign workflow.

iTero Element 5D Plus

Multi-modality · NIRI caries detection

The prior flagship and still actively sold. "5D" refers to 3D scan + color intraoral photo + NIRI (Near-Infrared Imaging) caries detection in a single wand. Element 5D received FDA 510(k) clearance K193659 in 2020 for the NIRI caries-detection feature.

Product imagery: Align Technology / iTero. Reproduced here for reference; please contact Align for licensing inquiries.

What Align/iTero Claim as Competitive Advantages

The following claims are published by Align/iTero on their own product pages. We list them as iTero positions them — 3DL has not independently benchmarked any of these claims. Clinicians comparing scanners are encouraged to evaluate against their own clinical needs.

• Direct Invisalign integration. One-click submission of iTero scans to Invisalign ClinCheck — Align positions this as their strongest workflow differentiator versus other scanner brands.
• Multi-modality oral health assessment (5D / Lumina). 3D model + intraoral camera + NIRI interproximal caries detection in one wand. iTero markets this as a "single device for multiple diagnostic aids."
• NIRI sensitivity (interproximal caries). Per iTero's Lumina page, NIRI is positioned as "66% more sensitive than bitewing X-rays" for interproximal caries detection, without ionizing radiation.
• Lumina — 3× field of view. Marketed as a "3× larger field of view" versus the prior Element generation, helping with edentulous spaces, dentures, and full-arch capture.
• Lumina — 2× faster scans. Per Align, scan speed is double the prior generation.
• Lumina — 50% smaller wand. Per Align, the Lumina wand is half the size of the Element wand for improved ergonomics.
• Photorealistic scans. Lumina is marketed as producing scans with photo-quality color, which Align claims can replace separate intraoral photos for Invisalign cases.
• Align Oral Health Suite. Suite of diagnostic-aid and patient-education visualizations layered on top of the scan; per Align, surveyed practices report increased treatment acceptance.
• Time savings. Per iTero, the integrated intraoral camera "saves an average 11 minutes per patient" versus capturing separate photos.

All numeric claims above are quoted from Align/iTero's published marketing pages and footnoted on those pages with the relevant Align internal data or commissioned study references. Reproduced here for transparency, not endorsement.

FDA & Regulatory Status

iTero intraoral scanners are regulated by the U.S. Food & Drug Administration as Class II medical devices. The most recent 510(k) clearances visible in the public openFDA database for iTero hardware are listed below; the multi-modality features (NIRI caries detection) appear under product code NTK ("Caries Detector, Laser Light, Transmission"). Earlier Element scanner-base clearances were filed by the predecessor entity Cadent.

Variants of the Lumina (e.g., a wireless version released after Lumina Pro) and the regional Element 5D / 5D Plus configurations each require their own valid 510(k) for U.S. sale. Clinicians can verify any specific model's current clearance status directly in the FDA's public 510(k) database.

Cloud Storage & Data Residency

iTero scanners write to Align's cloud platform — case management runs through the MyiTero portal and the broader Align ClinCheck infrastructure. Unlike 3Shape, Align does not publish a public per-region data-residency table; what they do publish is a list of cloud sub-processors and a global data-transfer framework.

Align Cloud Sub-Processors

Per iTero's own published Privacy Policy, Align's cloud and platform sub-processors include the following commercial cloud and infrastructure providers:

• Amazon Web Services (AWS)
• Microsoft Azure
• Heroku (Salesforce-owned PaaS)
• Salesforce + Salesforce Marketing Cloud
• Savvis (CenturyLink) — colocation / managed hosting
• SAP SE
• Tata Consultancy Services
• Alorica

Where Patient Data is Stored

Align's published Privacy Policy states that personal information "may be transferred internationally" and that Align relies on Binding Corporate Rules (BCRs) as its primary legal mechanism for cross-border data transfer. The policy does not list specific Microsoft Azure or AWS regions by customer geography.

U.S. dental practices should reasonably assume their iTero scans are stored in U.S.-region infrastructure (AWS and/or Azure), but Align's public documentation does not commit to a specific data center, region, or replication boundary. Practices with strict data-residency requirements should request a written sub-processor and region disclosure from Align before signing.

Compliance Status

• GDPR — Align is the named global data controller; uses Binding Corporate Rules approved by EU data-protection authorities.
• State privacy laws (US) — Align's Privacy Policy explicitly addresses California (CCPA/CPRA), Colorado, Utah, Virginia, Oregon, Montana, Texas, Tennessee, Indiana, Iowa, Delaware, and Connecticut.
• HIPAA — Align's public Privacy Policy does not explicitly publish HIPAA Business Associate Agreement (BAA) terms. Practices needing a BAA covering MyiTero / iTero cloud storage should contact Align directly to confirm BAA availability before storing identifiable patient information in the iTero platform.

Working With 3DL on an iTero Workflow

3DL accepts iTero scans through three routes:

• Direct from MyiTero. Add 3DL as a connected lab in your MyiTero account — cases are routed to our queue automatically with the scan, prescription, and any chair-side notes.
• STL / DCM export through the doctor portal at 3dlmi.com — works with any export from MyiTero.
• Invisalign-paired restorative cases. When a patient's Invisalign treatment also needs restorations (crown, veneer, implant), 3DL can design the restoration off the same iTero scan you've already submitted to Align.

If you are evaluating an iTero purchase and want to talk about scanner-to-lab fit, call (248) 919-7929.