Smile Dx

JSON twin: https://www.healthaidb.com/software/smile-dx.json

Company Name

Cube Click

Product URL

https://www.smiledx.com

Company URL

https://www.smiledx.com

Categories

• diagnostic Support
• clinical Care
• patient Facing
• Diagnostic
• Clinical

Summary

Smile Dx is an FDA-approved AI-powered dental diagnostic platform that enhances detection of cavities, root canal pathologies, and periodontal disease by analyzing dental X-rays at the pixel level.

Description

Smile Dx utilizes advanced AI algorithms to assist dentists in diagnosing dental conditions with improved accuracy, leading to better patient outcomes and increased treatment acceptance rates.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• ISO 13485:2016
• ISO/IEC 27001
• ISO/IEC 27017
• ISO/IEC 27018
• SOC 2 Type II
• HITRUST r2

Company Founding

2018

Company Offices

• United States

Compliance

• HIPAA
• FDA 510(k) clearance
• ISO 13485:2016
• ISO/IEC 27001
• ISO/IEC 27017
• ISO/IEC 27018
• SOC 2 Type II
• HITRUST r2

Customers

• 202,304 practicing dentists in the United States
• 1.4 billion dental X-Rays taken in America each year

Data Residency

US and Canada; multi-region cloud hosting (customer region options)

Data Standards

• DICOM
• HL7 v2
• HL7 v3
• CDA
• SNOMED CT
• ICD-10

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• AI-powered dental radiology analysis
• Cavity detection
• Periodontal disease detection
• Root canal identification
• FDA-approved

Id

SW0026

Integration Partners

• G2
• Capterra
• Health IT News

Integrations

• Dental imaging systems
• Electronic Health Records (EHR) systems
• Practice Management Software
• Patient portals
• Third-party clinical decision support systems
• Analytics platforms

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Clinical Decision Support System (CDSS)
• Patient engagement tools
• Reporting and analytics

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Business Associate Agreement (BAA) available
• Consent management controls
• Anonymization/de-identification support
• Data minimization controls

Product Code

SW0026

Product Name

Smile Dx

Ratings

• 5/5 on G2
• 4.7/5 on G2
• 4.5/5 on G2
• 4.4/5 on G2
• 4.3/5 on G2
• 4.2/5 on G2
• 4.1/5 on G2
• 4.0/5 on G2
• 3.9/5 on G2
• 3.8/5 on G2

Regions Available

• United States

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

2024

Security Features

• AES-256 encryption
• Encryption in transit (TLS)
• Role-Based Access Control (RBAC)
• Audit logs
• Two-Factor Authentication (2FA)

Specialties

• General Dentistry
• Periodontics
• Endodontics

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

• Windows 10 or later
• macOS 10.15 or later
• Linux (Ubuntu 20.04 or later)
• iOS 12 or later
• Android 9 or later

Target Users

• dentists
• dental hygienists
• dental technicians

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• Cube helps brands optimize their content production
• Cube makes it incredibly easy to expose our reporting data to our businesses

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Smile Dx",
  "company_name": "Cube Click",
  "product_url": "https://www.smiledx.com",
  "company_url": "https://www.smiledx.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0026",
  "summary": "Smile Dx is an FDA-approved AI-powered dental diagnostic platform that enhances detection of cavities, root canal pathologies, and periodontal disease by analyzing dental X-rays at the pixel level.",
  "description": "Smile Dx utilizes advanced AI algorithms to assist dentists in diagnosing dental conditions with improved accuracy, leading to better patient outcomes and increased treatment acceptance rates.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "patient Facing",
    "Diagnostic",
    "Clinical",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "dentists",
    "dental hygienists",
    "dental technicians"
  ],
  "specialties": [
    "General Dentistry",
    "Periodontics",
    "Endodontics"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "AI-powered dental radiology analysis",
    "Cavity detection",
    "Periodontal disease detection",
    "Root canal identification",
    "FDA-approved"
  ],
  "optional_modules": [
    "Clinical Decision Support System (CDSS)",
    "Patient engagement tools",
    "Reporting and analytics"
  ],
  "integrations": [
    "Dental imaging systems",
    "Electronic Health Records (EHR) systems",
    "Practice Management Software",
    "Patient portals",
    "Third-party clinical decision support systems",
    "Analytics platforms"
  ],
  "data_standards": [
    "DICOM",
    "HL7 v2",
    "HL7 v3",
    "CDA",
    "SNOMED CT",
    "ICD-10"
  ],
  "api_available": "unknown",
  "system_requirements": [
    "Windows 10 or later",
    "macOS 10.15 or later",
    "Linux (Ubuntu 20.04 or later)",
    "iOS 12 or later",
    "Android 9 or later"
  ],
  "compliance": [
    "HIPAA",
    "FDA 510(k) clearance",
    "ISO 13485:2016",
    "ISO/IEC 27001",
    "ISO/IEC 27017",
    "ISO/IEC 27018",
    "SOC 2 Type II",
    "HITRUST r2"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "ISO 13485:2016",
    "ISO/IEC 27001",
    "ISO/IEC 27017",
    "ISO/IEC 27018",
    "SOC 2 Type II",
    "HITRUST r2"
  ],
  "security_features": [
    "AES-256 encryption",
    "Encryption in transit (TLS)",
    "Role-Based Access Control (RBAC)",
    "Audit logs",
    "Two-Factor Authentication (2FA)"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Consent management controls",
    "Anonymization/de-identification support",
    "Data minimization controls"
  ],
  "data_residency": "US and Canada; multi-region cloud hosting (customer region options)",
  "customers": [
    "202,304 practicing dentists in the United States",
    "1.4 billion dental X-Rays taken in America each year"
  ],
  "user_reviews": [
    "Cube helps brands optimize their content production",
    "Cube makes it incredibly easy to expose our reporting data to our businesses"
  ],
  "ratings": [
    "5/5 on G2",
    "4.7/5 on G2",
    "4.5/5 on G2",
    "4.4/5 on G2",
    "4.3/5 on G2",
    "4.2/5 on G2",
    "4.1/5 on G2",
    "4.0/5 on G2",
    "3.9/5 on G2",
    "3.8/5 on G2"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2024",
  "integration_partners": [
    "G2",
    "Capterra",
    "Health IT News"
  ],
  "id": "SW0026",
  "slug": "smile-dx",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/smile-dx.json"
  }
}