Announcement • Feb 20
Dror Ortho-Design, Inc. Receives 510(K) FDA Clearance for Next-Generation Smile Correction Solution Dror Ortho-Design, Inc. announced that the U.S. Food and Drug Administration ("FDA") has granted 510(k) clearance for the Company's next-generation ZSmile Platform, or ZSmile. this milestone clearance validates ZSmile's approach to orthodontic treatment -- using proprietary pulsating air technology delivered through a single custom-made smart aligner designed to work painlessly while patients sleep -- and unlocks the pathway for the next step to full U.S. commercialization. ZSmile is the first and only reported FDA-cleared orthodontic system intended to correct people's smile usingumatic tooth movement technology. Unlike traditional clear aligners that may require dozens of trays and up to 22 hours of daily wear, ZSmile delivers treatment through a single custom aligner designed to be worn only while at home or during sleep. Patients are free to go about their day unencumbered, free to eat, drink, speak, and engage in professional and social life with no aligner in their mouth. ZSmile aims to be provide a painless, hassle-free, and entirely discreet smile correction experience. that has already been tested across more than 300 patients in clinical trials and other testing programs. Next-Generation ZSmile Platform: Key Innovations: Building on the Company's first-generation system, which received FDA clearance in April 2020, the next-generation Z Smile Platform incorporates significant technological advancements: Proprietary Pulsating Air Technology: A redesigned micropump and motor system quietly delivers calibratedumatic forces through a single smart aligner, designed for painless and effective tooth movement during sleep. AI-Powered Cloud Analytics: Proprietary artificial intelligence algorithms assist in analyzing tooth movement to assist in remote monitoring capabilities for practitioners. IoT-Connected Smart Aligner: Built-in Internet of Things (IoT) connectivity provides data transmission between the aligner, the patient’s smartphone application, and the practitioner’s dashboard, creating an integrated digital orthodontic ecosystem. Integrated Mobile Application: Smartphone app designed to be patients’ treatment concierge, providing real-time treatment tracking, compliance monitoring, and direct lines of communication with their dental provider. Single-Aligner Treatment Model: Unlike most conventional systems requiring dozens of sequential trays, ZSmile uses one custom-fabricated smart aligner for the entire treatment course, reducing material waste, practitioner chair time, and perceived patient burden compared to conventional systems. Announcement • Jan 13
Dror Ortho-Design, Inc. Secures Israeli Regulatory Approval to Market and Sell Its Next Generation Smile Correction Solution Dror Ortho-Design, Inc. announced that its second-generation ZSmile platform has received regulatory approval from the Israeli Ministry of Health's AMAR Division, the authority responsible for medical device regulation in Israel. The approval clears the path for Dror to bring to market a breakthrough orthodontic solution in that corrects patients' smiles overnight, eliminating the need to wear clear plastic aligners during waking hours. Powered by proprietary pulsating air technology delivered through a smart nighttime appliance, ZSmile represents a fundamental reimagining of how orthodontic treatment is delivered. The platform's companion mobile app enables real-time treatment monitoring and seamless patient-doctor communication. Announcement • Nov 18
Dror Ortho-Design, Inc. announced delayed 10-Q filing On 11/17/2025, Dror Ortho-Design, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. 
