{"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"}}