Smile Dx®

by Cube Click  · Based in United States → — Smarter Scans. Stronger Smiles.
Dentistry Radiology

Subscription-based model
Regulatory Status Disclosed

Overview

Smile Dx® is a next-generation, AI-powered dental diagnostic platform developed by Cube Click, Inc. It is designed to assist dental professionals in identifying various dental pathologies with enhanced accuracy. The platform analyzes dental X-rays at the radiographic pixel level to detect cavities (caries), root canals (periapical radiolucencies), and periodontal disease (gum and bone disease).

This cloud-based system is compatible with both digital and phosphor plate sensors, seamlessly integrating with existing dental imaging setups. Smile Dx® aims to improve diagnostic detection by an average of 19%, leading to better clinical outcomes and increased patient engagement and acceptance of treatment plans. It utilizes advanced Instance Segmentation technology for superior precision and presents color-coded AI results for clearer understanding by both the dentist and the patient.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered dental radiology analysis
  • Cavity (caries) detection (primary, secondary, and gross)
  • Root canal (periapical radiolucencies) identification
  • Periodontal disease (gum and bone disease) detection
  • Compatible with digital and phosphor plate sensors
  • Cloud-based platform
  • Enhances diagnostic accuracy (average 19% improvement)
  • Color-coded AI for better understanding by doctor and patient
  • Instance Segmentation technology for superior precision
  • Early detection for intervention and prevention

Use Cases

  • Assisting dentists in diagnosing dental conditions with improved accuracy
  • Enhancing clinical outcomes
  • Driving practice growth by increasing patient engagement and treatment acceptance
  • Reducing time spent on X-ray analysis
  • Early intervention and prevention of painful and costly dental procedures
  • Streamlining X-ray analysis workflows

What Physicians Need to Know

Dental X-Ray Analysis
Smile Dxu00ae is an FDA-approved AI-powered dental diagnostic platform that performs pixel-level analysis of dental X-rays. It identifies normal tooth anatomy, including jaw bone, enamel, dentin, nerves, and pulp, and detects various pathologies.
Caries Detection Accuracy
The platform is FDA-cleared for detecting primary, secondary, and gross caries (cavities) at the pixel level. Clinical studies indicate an average 19% improvement in diagnostic detection, addressing the issue of routine misdiagnosis. AI-assisted caries detection can achieve an overall accuracy of up to 93.40%.
Periodontal Assessment
Smile Dxu00ae empowers dentists to diagnose periodontal disease at the pixel level, assisting in the early identification of issues such as bone loss and gum inflammation.
Treatment Planning AI
The AI system contributes to more confident treatment plans and improved patient outcomes. Its cloud-based AI enhances clinical results and drives practice growth by increasing patient engagement and acceptance of proposed treatments.
Dental Imaging Integration
Smile Dxu00ae integrates with existing dental imaging systems and is compatible with both digital and phosphor plate sensors.
Practice Management Integration
The platform offers integrations with various Practice Management Software to streamline administrative and clinical workflows.
Patient Communication Tools
Smile Dxu00ae enhances patient understanding and boosts case acceptance by allowing patients to visualize AI-analyzed X-rays with color-coded diagnostic results, making diagnoses clearer and more tangible.
Physician Tip

To maximize the benefits of Smile Dxu00ae, leverage its AI for enhanced diagnostic accuracy in detecting caries and periodontal disease, leading to earlier intervention and improved patient outcomes. Utilize the AI-powered visual explanations during patient consultations to foster greater understanding and increase treatment acceptance. Integrate Smile Dxu00ae seamlessly with your existing imaging and practice management systems to optimize workflows and boost overall practice efficiency.

Smile Dxu00ae is designed for robust integration with existing dental imaging systems, supporting compatibility with both digital and phosphor plate sensors. It also facilitates integrations with various Practice Management Software and Electronic Health Records (EHR) systems, ensuring a cohesive and efficient digital workflow within the dental practice.

Details

Category Dental AI
Pricing Subscription-based model — Subscription-based model; contact for details.
DeploymentSaaS, on-premise, hybrid
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

SMILE Dx® received official approval from the U.S. Food and Drug Administration (FDA) on June 19, 2025. It is the first and only FDA-approved dental AI device compatible with both digital and phosphor plate sensors, and the first and only FDA-approved system for detecting primary, secondary, and gross caries. It is a prescription-only medical device that can only be used by licensed dentists.

Integrations
EHR Not specified
Specialties Dentistry, Radiology

What the Web Says

Smile Dxu00ae is an AI-powered diagnostic platform designed to help dentists identify cavities, root canals, and periodontal disease at the radiographic pixel level. It has received FDA approval and aims to improve diagnostic detection by an average of 19%. The platform is cloud-based and is marketed as a tool to enhance clinical outcomes and drive practice growth through increased patient engagement.

Overall: Positive

Strengths

  • FDA-approved for detecting various dental pathologies, including primary, secondary, and gross caries.
  • Compatible with both digital and phosphor plate sensors.
  • Aims to improve diagnostic detection by an average of 19%.
  • Cloud-based recurring revenue model.
  • Enhances clinical outcomes and drives practice growth by increasing patient engagement and treatment acceptance.
  • User-friendly interface for uploading, viewing, and analyzing multiple dental X-rays simultaneously.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra for Smile Dxu00ae (smiledx.ai).
  • Some general negative sentiment on Reddit regarding a different company with a similar name (Smile Direct Club) highlights issues with customer service, treatment efficacy, and hidden costs.

Based on reviews from: Dentistry Today, Innolitics, Dental AI Platform

Last updated: 2026-07-19

Ratings & Reviews

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Press & Coverage

Smile Dxu00ae powered by Cube Click, Inc.
SMILE Dxu00ae Is Now FDA Approved!
SMILE Dxu00ae has received FDA approval, transitioning its technology from potential to a deployable solution for dental diagnostics. This milestone signifies market readiness and aims to accelerate commercial growth and partnerships.
2025-05
Dentistry Today
Cube Click Secures FDA Approval for SMILE Dxu2014A Game-Changer in Dental AI Diagnostics
Cube Click, Inc. announced that its flagship medical device, SMILE Dx, has received official FDA approval. The AI-powered platform identifies cavities, root canals, and periodontal disease at the radiographic pixel level, addressing a significant challenge in dental diagnostics.
2025-06
Becker's Dental Review
The AI revolution in dentistry - Becker's Dental Review
Cube Click received FDA approval for Smile Dx, its AI-powered diagnostic platform that can identify caries, root canals and periodontal disease at the radiographic pixel level. This is part of a broader trend of AI advancements in dentistry, with several companies receiving FDA clearances and forming partnerships.
2025-06
Business Wire
Cube Click, Inc. Secures FDA Approval for SMILE Dxu2014A Game-Changer in Dental AI Diagnostics
Cube Click, Inc. announced FDA approval for SMILE Dx, an AI-powered diagnostic platform for dental issues. The company highlights the device's ability to improve diagnostic detection by an average of 19% and its potential to unlock significant revenue streams for dental practices.
2025-06
Start LLC
Cube Click, Inc. Secures FDA Approval for SMILE Dxu2014A Game-Changer in Dental AI Diagnostics
Cube Click, Inc. has secured FDA approval for SMILE Dxu00ae, an AI-powered diagnostic platform for dental radiography. It is noted as the first and only FDA-cleared dental AI device compatible with both digital and phosphor plate sensors.
2025-06
Innolitics
The Dental AI Revolution: A Comprehensive Analysis of 510(k) Clearances (2021-2025)
Smile Dx is highlighted as one of the 18 dental AI devices cleared by the FDA in 2025, showcasing the rapid growth in the dental AI market. Innolitics, a partner in its development, notes that Smile Dx significantly improves the detection of caries and periapical radiolucencies.
2025-12
PubMed Central (PMC)
FDA-Approved AI Solutions in Dental Imaging: A Narrative Review of Applications, Evidence, and Outlook - PMC
This narrative review, covering through July 2025, identifies FDA-cleared AI systems for dentomaxillofacial imaging, including Cube Click Smile Dx. It notes that most platforms, including Smile Dx, had no peer-reviewed publications identified for technical performance or clinical application at the time of review.
2025-12
Odontologos.com
FDA-Approved AI Solutions in Dental Imaging: A Narrative Review of Applications, Evidence, and Outlook
This review, with coverage through July 2025, discusses FDA-approved AI solutions in dental imaging, including Cube Click Smile Dx, which is indicated exclusively for adult populations. The review highlights the recent trend in technological innovation and regulatory oversight in dental AI.
2026-02

Videos

Product demos, reviews, and walkthroughs for Smile Dx®.

View all on YouTube

Frequently Asked Questions

Smile Dxu00ae is a cloud-based platform designed for seamless integration with your existing dental imaging systems, Electronic Health Records (EHR) systems, and practice management software. It analyzes dental X-rays and provides instant, color-coded diagnostic results to streamline analysis and enhance accuracy.
Smile Dxu00ae is an AI-powered diagnostic platform that enhances the detection of cavities (caries), root canal pathologies (periapical radiolucencies), and periodontal disease by analyzing dental X-rays at the pixel level. It is FDA-approved for detecting primary, secondary, and gross caries.
Smile Dxu00ae is FDA-approved, having received 510(k) clearance from the U.S. Food and Drug Administration. It also complies with HIPAA and holds certifications such as ISO 13485:2016, ISO/IEC 27001, ISO/IEC 27017, ISO/IEC 27018, SOC 2 Type II, and HITRUST r2.
Smile Dxu00ae adheres to stringent compliance standards, including HIPAA, ISO/IEC 27001, ISO/IEC 27017, ISO/IEC 27018, SOC 2 Type II, and HITRUST r2. It offers multi-region cloud hosting with customer region options for data residency, ensuring robust data protection.
Several AI-powered dental diagnostic platforms exist, including Overjet, Pearl, and VideaHealth, which also analyze dental X-rays for pathologies like caries and bone loss. Other alternatives in dental imaging and practice management software include Curve Dental, Oryx Dental Software, and DEXIS Imaging Suite, some of which integrate AI features.
Smile Dxu00ae operates on a subscription-based model, designed to provide affordable access to its AI technology. This recurring revenue model is positioned for rapid market penetration and scalability.
While Smile Dxu00ae significantly improves diagnostic accuracy, it is a prescription-only medical device intended to assist licensed dentists, not replace their professional judgment. Clinical outcomes can depend on various factors and are not guaranteed, as AI suggestions still require human evaluation and adaptation to clinical possibilities.
No, Smile Dxu00ae is designed as an AI-powered diagnostic *support* tool to assist dentists in identifying dental conditions with improved accuracy. It provides more complete information by analyzing X-rays at the pixel level, but the final diagnosis and treatment plan remain the responsibility of the licensed dentist.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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