Overjet, Inc. - FDA 510(k) Cleared Devices

Overjet, Inc. is a dental AI software company based in Boston, US. The company develops artificial intelligence platforms for dental imaging, clinical diagnosis, and administrative automation. Overjet serves dentists, dental service organizations, insurers, and dental educators with FDA-cleared AI solutions.

Overjet has received 12 FDA 510(k) clearances from 12 total submissions since its first clearance in 2021. The company specializes exclusively in Radiology devices, with all submissions focused on AI-assisted imaging analysis and clinical decision support. The latest clearance was issued in 2026, confirming active regulatory engagement.

Recent cleared devices include the Overjet Iris Intelligent Imaging System, CBCT Assist, Image Enhancement Assist, and multiple AI-assisted diagnostic tools for caries detection, calculus identification, and periapical radiolucency assessment. These products reflect the company's focus on automating dental image analysis and enhancing clinical workflows through machine learning.

Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.

2 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.