Overjet Iris Intelligent Imaging System— 510(k) K253930

Name: FDA 510(k) clearance K253930
Creator: U.S. Food and Drug Administration
Published: 2026-04-10

Substantially Equivalent

Overjet, Inc.

FDA 510(k) clearance K253930 for Overjet Iris Intelligent Imaging System, Substantially Equivalent on 2026-04-10. Applicant: Overjet, Inc.. Device class: 2.

Summary

Overjet makes AI software for dental radiographs, and the Iris Intelligent Imaging System is filed under QIH, automated radiological image processing software. The record doesn't say which analyses Iris performs.

Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).

Overjet filed from Boston, Massachusetts. Review took 122 days (December 9, 2025 to April 10, 2026). The company has several earlier clearances for dental radiograph analysis.

Clearance details

Applicant: Overjet, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-12-09
Decision date: 2026-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Overjet, Inc.

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K261059 — Overjet Multi-Image Caries and Charting Assist2026-08-06
K251514 — Overjet CBCT Assist2025-12-05
K241681 — Overjet Image Enhancement Assist2024-09-09
K241684 — Overjet Charting Assist2024-08-27
K233738 — Overjet Caries Assist-Pediatric2024-03-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.