1. On April 10, 2026, the U.S. FDA granted 510(k) clearance for 3Shape Dx Software (announced April 28, 2026). The AI-assistive diagnostic solution is now commercially availAble in the United States.
2. In April 2026, the FDA also granted 510(k) clearance for the 3Shape Ortho System clear aligner workflow, expanding the company's orthodontic digital capabilities.
Company Profile (Updated April 2026)
3Shape A/S is a global innovator in digital dentistry headquartered in Copenhagen, Denmark. Founded in 2000, the company has grown into one of the most influential technology providers in the Dental industry, empowering dental professionals to deliver superior patient care through advanced digital workflows. 3Shape employs more than 2,200 dedicated professionals and serves customers in 100+ countries worldwide.
Development History:
- 2000: Founded in Denmark by two graduate students with a vision to digitize dentistry
- 2001-2010: Pioneered 3D scanning technology for dental lABS and introduced early intraoral scanning concepts
- 2011-2015: Launched the TRIOS intraoral scanner series, Rapidly gaining market share in digital impression technology
- 2021: EQT, a global private equity firm, became a major shareholder, providing capital for accelerated growth and innovation
- 2024 (May): Launched Unite 3Rd Generation, enabling cloud storage and access to TRIOS scans from any device
- 2025 (March): Launched TRIOS 6, the next-generation intraoral scanner featuring hyperspectral imaging and integrated AI diagnostics
- 2026 (January 27): Appointed Rasmus Hannemann as Senior Vice President, Portfolio ＆ Product Strategy, effective March 9, 2026
- 2026 (February): Resolved a critical Dental System code signing certificate issue affecting global lab users
- 2026 (April 10): ACHieved U.S. FDA 510(k) clearance for Dx AI-assistive diagnostic software; announced publicly on April 28, 2026
- 2026 (April): Achieved U.S. FDA 510(k) clearance for the Ortho System clear aligner workflow
Core Mission: To advance and connect dental practices and labs through award-winning digital solutions, ensuring superior dental care for every patient, every time.
FDA 510(k) Clearance for Dx Software (April 2026)
Regulatory Approval Overview
Product: 3Shape Dx Software (Dx Plus and Dx Standard)
Regulatory Status: FDA 510(k) Premarket Notification cleared on April 10, 2026; announced April 28, 2026
Indication for Use: Aids in the diagnosis of key oral health conditions and assessment of changes in teeth and gingiva in adult patients
Compatible Hardware:
- Dx Plus: Exclusively compatible with 3Shape TRIOS 6; AI-assistive detection of surface/proximal caries, plaque, tooth wear, and gingival recession with suggested severity of each pathology's progression
- Dx Standard: Compatible with all TRIOS models except TRIOS Core; manual tracking and quantification of dentition changes
Market Availability: Available in the U.S. starting April 2026; previously launched in Europe, Middle East, Africa, South America, and Canada in 2025
CEO Statement: Jacob Paulsen, 3Shape CEO: "Receiving FDA 510(k) clearance for Dx underscores our commitment to responsible innovation and to delivering digital solutions that meet the highest clinical and regulatory standards."
Core Products ＆ Solutions
Intraoral Scanners (TRIOS Series)
TRIOS 6 (Flagship, launched March 2025):
- Hyperspectral Technology: Captures data from white, fluorescent, and near-infrared light simultaneously for enhanced diagnostic detail
- Scan Resolution: Up to 110% higher scan resolution compared to previous TRIOS models
- ScanAssist Technology: Patented intelligent alignment with haptic feedback guidance
- AI Diagnostics: Integrated Dx Plus software for real-time AI-assistive diagnosis; the only scanner in the 3Shape portfolio that is Dx Plus ready
- Patient Engagement: Compatible with the DentalHealth iPhone app for patient communication
- Performance: Scanned more than 35 million patients in 2025 (24% year-over-year increase); equivalent to one patient scanned every 0.8 seconds
- Recognition: Winner of the European Product Design Award (EPDA) 2025
- License: Dongle-free delivery; runs exclusively on Unite 24.1 with online license activation
- Price (North America): $27,900 USD base scanner (excluding tax and shipping); promotional bundles with laptop available
TRIOS 5: High-performance wireless intraoral scanner with proven accuracy and ergonomic design
TRIOS 3: Established workhorse scanner widely adopted for restorative and orthodontic workflows
TRIOS Core: Entry-level digital impression solution for practices beginning their digital journey
Note: TRIOS 4 has been discontinued with the launch of TRIOS 6.
CAD/CAM Software ＆ Platforms
3Shape Dental System 2025:
- AI Bite Alignment: Automatically analyzes dental arches and places them in static occlusion based on anatomical norms, delivering reliable bite setups in seconds
- AI Tooth Outlining: Automated margin line detection and tooth outlining for copy denture workflows
- AI Design Proposals: Free AI-powered design proposals for crowns, inlays, onlays, and bridges (up to 4 units) Included with LabCare subscription
3Shape Unite Platform: Cloud-based collaboration hub connecting clinics, labs, and third-party applications; integrates with 60+ Practice Management Systems
3Shape LMS: Lab Management Software with native integration to Dental System and TRIOS scanners, eliminating double data entry
Diagnostic ＆ Treatment Planning Software
3Shape Dx / Dx Plus: AI-assistive diagnostic software for caries detection, plaque visualization, tooth wear monitoring, and gingival recession assessment
3Shape Implant Studio: Digital implant planning software with simplified workflows for full-arch restorative planning, including All-on-4, All-on-6, multi-unit abutments (MUA), and screw-retained crowns
3Shape DentalHealth App: Patient-facing smartphone application enabling patients to view their scans and track oral health conditions
Lab Scanners ＆ Hardware
- High-precision dental lab scanners for model scanning and articulator integration
- Open-architecture solutions supporting STL, PLY, DCM, and industry-standard file formats
All-on-X Workflow
- TrUAButment ioConnect Workflow: Dedicated All-on-X workflow using ioConnect scan flags with guided animations and text instructions
- Straumann Exact + TRIOS Workflow: Dedicated full-arch solution with Straumann Exact; teaser available in software with full release in Q1 2026
Market Performance ＆ Adoption Metrics
2025-2026 Key Metrics
- TRIOS Patient Scans (2025): 35 million+ patients scanned globally, representing a 24% year-over-year increase
- IOS Market Penetration: Intraoral scanner adoption exceeds 60% in the United States and Northern Europe, with TRIOS established as a standard-of-care device
- Global Reach: Products distributed in 100+ countries through authorized resellers and direct channels
- Workforce: 2,200+ employees worldwide, with significant R＆D and engineering teams based in Copenhagen
Company Information
Corporate Overview
Company Name: 3Shape A/S
Founded: 2000
Headquarters: Copenhagen, Denmark
Legal Status: Private company
Major Shareholder: EQT (global private equity firm, since 2021)
Industry: Medical Technology / Digital Dentistry / Diagnostic Equipment
Employees: 2,200+
Global Presence: 100+ countries
Leadership
Chief Executive Officer: Jacob Paulsen (Jacob Vishof Paulsen)
- LeADINg 3Shape's global strategy, innovation roadmap, and regulatory expansion
- Guided the company through the FDA clearance process for Dx software in 2026
Senior Vice President, Portfolio ＆ Product Strategy: Rasmus Hannemann
- Appointed January 27, 2026; effective March 9, 2026
- Former Coloplast Vice President, Group Development ＆ Strategy; leads product strategy, innovation alignment, and commercial execution
Senior Product Director (Labs): Christian Rytter
- Oversees dental lab software and AI-powered workflow development
2026 Operational Events
Dental System Certificate Issue (February 2026)
- Incident: On February 18, 2026, a critical issue was identified affecting Dental System 2024 and 2025 users globally. A code signing certificate expiration caused disruptions to 3Shape Automate (AI Design proposals), Cloud License authentication, and 3Shape Account sign-in
- Impact: Users experienced subscription errors, disabled AI Design proposals, and inability to sign into 3Shape Account in Dental Manager and Control Panel
- Resolution: Official patches released for Dental System 2024 (24.1.4) and 2025 (25.2.1) on February 19, 2026. A follow-up patch (DS 2.25.2.2 and DS 2.24.1.5) was released on March 23, 2026, after a precautionary certificate revocation affected some patched systems
- Status: Issue fully resolved; all customers advised to update to latest patched versions
Global Market ＆ Competitive Landscape
Primary Markets
North America: Major market with FDA-cleared products; strong adoption of TRIOS in U.S. and Canadian dental practices
Europe: Home market with deep penetration; headquarters and primary R＆D operations in Denmark
Asia-Pacific: Rapidly growing market with expanding reseller networks
Middle East, Africa ＆ South America: Emerging markets with increasing digital dentistry adoption
Key Competitors
- Align Technology (iTero): Leading competitor in intraoral scanning; owner of Invisalign, exocad, and Cubicure
- Dentsply Sirona (CEREC / Primescan): Integrated chairside CAD/CAM ecosystem
- Medit (i900 / i700): Korean manufacturer offering competitive open-platform scanners
- SHINING 3D (Aoralscan Elite / Elf): Chinese manufacturer with intraoral photogrammetry technology
- Alliedstar (Sensa): Emerging competitor with aggressive pricing
- Carestream Dental: Dental imaging and software solutions
Competitive Advantages
- AI Leadership: First-to-market AI-assistive diagnostics for intraoral scans (Dx Plus)
- Scan Quality: TRIOS 6 recognized for highest-resolution scanning and dense mesh output
- Ecosystem Integration: Seamless workflow from scanning to design to manufacturing via Unite cloud platform; 60+ Practice Management System integrations
- Open Architecture: Support for STL, PLY, DCM, and broad third-party software compatibility
- Regulatory Excellence: Strong track record of FDA, CE, and international regulatory clearances
- Brand Recognition: 25+ years of innovation; multiple international design and technology awards
2026 Outlook ＆ Strategic Priorities
Technology Roadmap
- AI Expansion: Extend AI diagnostic capabilities beyond caries and plaque to periodontal and endodontic applications
- 3D Printing Integration: Deepen partnerships and workflows for direct 3D-printed restorative devices
- Cloud-First Platform: Expand 3Shape Unite as the central hub for connected dental ecosystems
- Full-Arch Solutions: Enhance Implant Studio for complex full-arch implant and immediate-load workflows
- Patient Engagement: Scale the DentalHealth app and similar consumer-facing tools to drive treatment acceptance
Market Strategy
- U.S. Market Growth: Capitalize on FDA-cleared Dx software and Ortho System to drive TRIOS 6 adoption among American clinicians
- Lab Efficiency: Continue deploying AI-powered automation in Dental System to reduce manual design time
- Global Expansion: Increase penetration in Asia-Pacific, Latin America, and emerging European markets
- Interoperability: Advocate for open standards and seamless data exchange across the dental technology landscape
Contact Information
Global Headquarters
Address: Copenhagen, Denmark
Website: www.3shape.com
Corporate Communications
Director and Head of Corporate Communications: Lina Danstrup
Email: lina.danstrup@3shape.com
Product Support ＆ Sales
Contact your local 3Shape reseller or representative for purchase information, trials, and technical support. Eligible customers can visit webshop.3shape.com to start a trial.
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