3Shape — TRIOS Intraoral Scanners
3Shape is a Danish digital-dentistry company best known for the TRIOS intraoral scanner line. This page is a neutral manufacturer profile — parent company, where the hardware is made, the current scanner lineup, and the competitive claims 3Shape themselves publish. All facts on this page are sourced from 3Shape's own documentation; see citations at the end of each section.
About 3Shape
3Shape was founded in 2000 by Danish university students Nikolaj Deichmann (business) and Tais Clausen (engineering) and initially worked with hearing-aid companies before pivoting to dentistry around 2005. Per the company's own history page, 3Shape opened a manufacturing site in Poland during that period — the same facility that produces the TRIOS hardware today — and a software-development office in Kyiv, Ukraine. The company remains privately held, with headquarters in Copenhagen.
3Shape reports 2,330 employees globally across 28+ countries, products sold in 100+ markets, and 650+ patents. Per 3Shape, 26.6 million patients were scanned with a TRIOS scanner in 2024.
Product Timeline
A condensed timeline drawn from 3Shape's published company history.
- 20003Shape founded in Denmark; early work focused on hearing-aid 3D scanning.
- 2005First dental lab software released. Manufacturing site opens in Poland; per 3Shape, the facility quickly ramped to ~1,000 scanners per year.
- 2011First TRIOS intraoral scanner launched — per 3Shape, the first IOS on the market to enable powder-free scanning.
- 2015TRIOS 3 released, faster and more ergonomic than the prior generation per 3Shape.
- 2017TRIOS 3 Wireless — described by 3Shape as the world's first wireless intraoral scanner.
- 20213Shape Unite ecosystem launched — a workflow platform that connects TRIOS scans to labs, software, and treatment partners.
- 2024+TRIOS 6 Wireless released as 3Shape's current flagship intraoral scanner.
Current Intraoral Scanner Lineup (2026)
3Shape currently markets four intraoral scanner models, listed below from flagship to entry. All four feed scans into the same 3Shape Unite workflow platform.
TRIOS 6 Wireless
Flagship · Wireless
3Shape's current flagship. Marketed by 3Shape as offering "hyperspectral" capture (three light sources in a single scan) and, per 3Shape, "110% higher resolution" versus the prior generation, paired with AI-assistive diagnostics via TRIOS Dx Plus.
TRIOS 5 Wireless
Acclaimed mid-tier · Wireless
Wireless scanner introduced before TRIOS 6 and still actively sold. 3Shape highlights ergonomics, calibration-free operation, ScanAssist intelligent alignment, and hygienic single-piece design.
TRIOS 3 Wired
Proven workhorse · Wired
Long-running TRIOS generation, repositioned by 3Shape as "the trusted choice." Wired only; full access to 3Shape Unite Store apps and patient-engagement features.
TRIOS Core Wired
Entry · Wired
3Shape's entry-level wired scanner — "essential functionality" per 3Shape's positioning. Targets price-sensitive practices wanting a TRIOS-grade scan without the wireless/AI feature set.
Product renders: 3Shape A/S. Imagery is the property of 3Shape and is reproduced here for reference; please contact 3Shape directly for licensing inquiries.
Lab Scanners (for context)
3Shape also produces benchtop lab scanners — the F8 and the E series — that pair with their Dental System CAD software. Lab scanners are outside the scope of this clinical page; 3DL processes TRIOS intraoral scans regardless of which lab scanner the practice uses.
What 3Shape Claims as Competitive Advantages
The following are 3Shape's own published claims about TRIOS. We list them as 3Shape positions them — 3DL has not independently benchmarked these claims, and clinicians comparing scanners are encouraged to evaluate against their own clinical needs.
- Scan volume at scale. 3Shape states "every 0.9 seconds, a patient is scanned with a TRIOS scanner," based on 26.6 million patients scanned with TRIOS in 2024.
- Industry recognition. 3Shape positions TRIOS as a "12× Cellerant Best of Class Award winner."
- Hyperspectral capture (TRIOS 6). 3Shape markets TRIOS 6 as capturing three light sources in a single scan, which they say enables their "best-ever scan quality."
- Resolution improvement (TRIOS 6). 3Shape claims "110% higher resolution" on TRIOS 6 versus the previous generation.
- AI-assistive diagnostics. Marketed under TRIOS Dx / Dx Plus — analysis, comparison, and monitoring tools layered onto the scan.
- ScanAssist intelligent alignment. 3Shape's algorithm for aligning scan segments without per-tooth user guidance.
- Calibration-free scanning. Per 3Shape, no daily calibration step required on TRIOS 5 and TRIOS 6.
- Wireless option. 3Shape states they were first to market with a wireless IOS in 2017; TRIOS 5 and TRIOS 6 remain wireless.
- Hygienic design. 3Shape highlights minimized cross-contamination through a single-piece body and autoclavable / Ready Tip options.
- Workflow ecosystem. 3Shape Unite provides one-click connectivity to labs, PMS providers, manufacturing partners, and thousands of apps in the Unite Store — including a direct Invisalign connection on supported models.
Claims sourced verbatim from 3Shape's TRIOS portfolio page; descriptive wording is theirs, not 3DL's.
FDA & Regulatory Status
3Shape's intraoral scanners are regulated by the U.S. Food & Drug Administration as Class II medical devices under product code NBL ("Optical Impression System for Computer Assisted Design and Manufacturing"). Each hardware variant must receive its own 510(k) clearance ("substantially equivalent" determination) before it can be marketed in the United States.
The following 510(k) clearances filed by 3Shape's manufacturing entity (3Shape TRIOS A/S, Copenhagen) appear in the public openFDA database as of May 2026:
| 510(k) Number | Device | Type | Cleared |
|---|---|---|---|
K221249 | L1P-1F (TRIOS 5) | Intraoral scanner hardware | Sep 16, 2022 |
K242103 | TRIOS Ready Tip | Reusable scanner tip (accessory) | Apr 4, 2025 |
K260082 | TRIOS Dx (R1) | AI-assistive diagnostic software | Apr 10, 2026 |
3Shape also holds additional 510(k) clearances for its CAD software, including Implant Studio (K141570, K152078, K202256), Ortho System (multiple clearances), Abutment Designer (K151455), Splint Design (K191911), and Abutment Design (K200100).
Earlier TRIOS hardware generations (TRIOS, TRIOS 3, TRIOS 4) and the current flagship TRIOS 6 each require their own valid 510(k) clearance to be sold in the U.S. — if a specific model isn't listed in the table above, clinicians can verify its current status directly in the FDA's public 510(k) database before purchase.
Cloud Storage & Data Residency
3Shape offers cloud-based services for storing and transmitting patient scans. These are optional — TRIOS scans can also be kept locally on the practice computer or an in-clinic server, with no cloud component.
3Shape Cloud Services
Per 3Shape's Data Processing Agreement, the company operates four cloud services that handle patient data:
- 3Shape Unite Cloud — the workflow platform that comes with TRIOS; case routing, app store, and scan storage.
- 3Shape Communicate — case sharing between clinic and lab.
- 3Shape Cloud Storage — long-term patient case archive.
- 3Shape Lab Management Software (LMS) — lab-side case management.
Where Patient Data is Physically Stored
3Shape publishes a public, customer-region-keyed data-residency table. For Unite Cloud / Communicate / Cloud Storage, patient cases are stored in:
| Customer Region | Cloud Provider | Data Center Region | Physical Location |
|---|---|---|---|
| Europe | Microsoft Azure | North Europe | Ireland |
| North & South America | Microsoft Azure | East US | Virginia, USA |
| Asia-Pacific (except China) | Microsoft Azure | East Asia | Hong Kong |
| China | 21Vianet Cloud | — | Shanghai, China |
For 3Shape Lab Management Software (LMS), the regions differ slightly — Europe → Azure North Europe (Ireland); Americas → Azure Central US (Iowa, USA); Asia-Pacific → Azure East Asia (Hong Kong).
3Shape states their guiding principle is to store customer patient data "in the region closest to the customer's location." Practices located in the United States therefore have their TRIOS Unite / Communicate scans stored in Microsoft Azure's East US region (Virginia).
Compliance & Certifications
- ISO 27001 and ISO 27701 certified at the 3Shape Group level (per 3Shape's Privacy & Compliance Center).
- GDPR — 3Shape A/S (Copenhagen) is the named EU data controller.
- EU-U.S. Data Privacy Framework — used as one legal basis for transferring personal information from the EU/UK to the United States.
- Standard Contractual Clauses — used as the data-transfer mechanism where the Data Privacy Framework does not apply.
- Data Protection Officer contact: dpo@3Shape.com.
HIPAA note: 3Shape does not publish an explicit HIPAA Business Associate Agreement (BAA) on its public privacy pages. U.S. dental practices that need to confirm BAA availability for TRIOS cloud services should contact 3Shape directly before storing identifiable patient information in 3Shape Unite Cloud.
Working With 3DL on a 3Shape Workflow
3DL accepts TRIOS scans through three routes:
- Direct via 3Shape Communicate / Unite. Add 3DL as a connected lab in your TRIOS Unite account — scans arrive in our queue automatically.
- STL / PLY upload through the doctor portal at 3dlmi.com — works with any export from your TRIOS.
- 3Shape Implant Studio case files (DCM) for surgical-guide and implant-restoration workflows.
We use 3Shape Dental System and Implant Studio in-house for design, with full scan-body library coverage across the 23 implant systems we support. If you are evaluating a TRIOS purchase and want to talk about scanner-to-lab fit, call (248) 919-7929.
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