Denti.AI announces the groundbreaking FDA 510(k) clearance of Denti.AI Detect, a revolutionary AI-powered imaging solution, amplifying disease detection capabilities in intra- and extraoral dental radiography and charting automation.TORONTO, Oct. 25, 2023 /PRNewswire/ -- Denti.AI, a pioneer in leveraging Artificial Intelligence for dental pathology detection, odontogram and periodontal charting automation, proudly announces the 510(k) clearance by the FDA of its innovative product, Denti.AI Detect.

Denti.AI宣布开创性的FDA 510（k）Denti.AI Detect清除，这是一种革命性的AI动力成像解决方案，可放大口腔内和口腔外牙科放射照相和制图自动化中的疾病检测能力。多伦多，2023年10月25日/PRNewswire/-Denti.AI，利用人工智能进行牙科病理检测，牙周图和牙周图表自动化的先驱，自豪地宣布FDA批准其创新产品510（k），Denti.AI检测。

This state-of-the-art imaging solution is engineered to aid dental professionals in identifying prevalent dental diseases such as caries, periapical lesions, and bone loss from dental x-rays. Clinical studies reveal a notable enhancement in disease detection by all the two dozen participating dentists, unlocking 26% extra treatment opportunities with Denti.AI Detect..

这种最先进的成像解决方案旨在帮助牙科专业人员识别流行的牙科疾病，如龋齿，根尖周病变和牙科x射线骨质流失。临床研究显示，所有二十多名参与牙医的疾病检测显着增强，Denti.AI检测释放了26%的额外治疗机会。。

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DENTI.AI PIONEERS FDA-CLEARED PATHOLOGY DETECTION IN BOTH PANORAMIC AND INTRAORAL X-RAYS WITH LAUNCH OF DENTI.AI DETECT

DENTI.AI推出了DENTI.AI DETECT，开创了FDA批准的全景和口内X射线病理检测

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Illustration of Combined Denti.AI Detect and Auto-Chart Features

结合Denti.AI检测和自动图表功能的插图

Following the prior clearance of Denti.AI Auto-Chart in November 2022, a breakthrough in automating odontogram charting of restorations, root canals, implants, crowns, and missing teeth, Denti.AI Detect now integrates with Auto-Chart to further refine disease charting and treatment plan coding in multiple integrated Practice Management Systems (PMS).

继2022年11月Denti.AI Auto Chart获得批准后，Denti.AI Detect在修复体，根管，种植体，牙冠和缺失牙齿的牙齿图表自动化方面取得了突破，现在已与Auto Chart集成在一起，以进一步完善疾病图表和多个综合实践管理系统（PMS）中的治疗计划编码。

This integration manifests a significant stride towards optimizing dental practice workflows and enhancing patient care..

这种整合显示了优化牙科实践工作流程和加强患者护理的重大步伐。。

A key distinguishing feature of Denti.AI Detect is its industry-first FDA clearance for disease detection on panoramic images. Denti.AI also stands as the only dental AI company to have secured clearance for all three major dental concerns: caries, periapical radiolucencies, and bone levels, marking a monumental achievement in the dental technology landscape..

Denti.AI检测的一个关键区别特征是其行业首个FDA批准用于全景图像疾病检测。Denti.AI也是唯一一家获得所有三大牙科问题许可的牙科AI公司：龋齿，根尖周射线可透性和骨骼水平，标志着牙科技术领域的巨大成就。。

Denti.AI Imaging Products

Denti.AI成像产品

Other Dental AI Companies

其他牙科AI公司

Supported Modalities

支持模式

Intraoral (Bitewing, Periapical)Extraoral (Panoramic, Bitewing)

口内（咬合，根尖周）口外（全景，咬合）

Intraoral (Bitewing, Periapical)

口内（咬合，根尖周）

Diagnostic Findings

诊断结果

All three of Caries, Periapical Radiolucency, Bone Level

所有三个龋齿，根尖周射线可透性，骨水平

No other company has all three cleared

没有其他公司清除所有三个

Presentation & Automation Features

演示和自动化功能

Manually Added FindingsTooth NumberingFMX ViewAI Confidence ScoreOdontogram ChartingTreatment PlanningPatient ReportTooth-Focused View

手动添加FindingsTooth NumberingFMX ViewAI Confidence Scoredontogram图表治疗计划患者报告牙齿聚焦视图

Manually Added FindingsTooth NumberingFMX View

手动添加FindingsTooth编号FMX视图

Table 1 Comparison of Denti.AI Imaging Products with Other AI-First Companies Based on FDA Clearance DocumentsDr. Edward Gelfand, owner of over 30 dental practices and partner of the largest Canadian DSO, extolled the effectiveness of Denti.AI Detect saying, 'The ability of Denti.AI Detect to uncover missed diseases has been a game-changer in not only identifying treatment opportunities but also in educating our patients.

表1基于FDA批准文件R的Denti.AI成像产品与其他AI第一公司的比较。拥有30多种牙科实践和加拿大最大的DSO合作伙伴的Edward Gelfand赞扬了Denti.AI Detect的有效性，他说：“Denti.AI Detect发现遗漏疾病的能力不仅可以识别治疗机会，而且还可以教育我们的患者。

Our best dentists attest to the indispensable nature of this tool in their practice.'Before its FDA clearance, Denti.AI Detect had already been licensed by Canada Health and extensively employed across multiple dental practices in Canada, further demonstrating its practical utility and reliability.Dr.

我们最好的牙医证明了这种工具在实践中不可或缺的性质在FDA批准之前，Denti.AI Detect已经获得加拿大卫生部的许可，并广泛应用于加拿大的多种牙科实践，进一步证明了其实用性和可靠性。博士。

Jonathan B. Levine, owner of the prestigious multi-specialty clinic JBL NYC and Chairman/Founder of innovative dental technology company GLOScience, shared his positive experience, 'After the rigorous research of Denti.AI Detect in our clinic over many months, I am thrilled to finally become a customer.

着名的多专科诊所JBL NYC的所有者兼创新牙科技术公司GLOScience的主席/创始人Jonathan B.Levine分享了他的积极经验，“经过数月对Denti.AI Detect在我们诊所进行严格研究后，我很高兴终于成为客户。

The technology has proven itself invaluable.'Denti.AI Founder and CEO, Dmitry Tuzoff, reflected on the journey, 'The realization of Denti.AI Detect clearance signifies countless hours of dedication from our team. The introduction of panoramic imaging technology, especially, propels our product to the forefront, addressing the growing usage of such imaging practices across North America.'As part of its launch celebration, Denti.AI is offering special pricing terms for Denti.AI Detect & Auto-Chart until the end of the year.

这项技术已被证明是无价的Denti.AI创始人兼首席执行官Dmitry Tuzoff反映了这段旅程，“Denti.AI Detect clearance的实现意味着我们团队无数小时的奉献精神。特别是全景成像技术的引入使我们的产品走到了最前沿，解决了北美地区这种成像实践的日益普及问题作为推出庆祝活动的一部分，Denti.AI将为Denti.AI Detect＆Auto Chart提供特殊定价条款，直至年底。

Interested parties are encouraged to explore this opportunity by filling out the form at www.denti.ai.About Denti.AI: Established in 2017, Denti.AI employs AI to decipher pathologies, past treatments, and anatomical features from dental x.

鼓励有关各方通过填写www.denti.ai.About denti.ai:2017年成立的表格来探索这一机会，denti.ai使用ai来破译牙科x的病理，过去的治疗和解剖特征。