Overjet Multi-Image Caries and Charting Assist— 510(k) K261059
Substantially EquivalentOverjet, Inc.
FDA 510(k) clearance K261059 for Overjet Multi-Image Caries and Charting Assist, Substantially Equivalent on 2026-08-06. Applicant: Overjet, Inc.. Device class: 2.
Summary
Overjet's Overjet Multi-Image Caries and Charting Assist is filed under product code MYN, medical image analyzers. The record has no description beyond the name and that code.
Class II, 21 CFR 892.2070. Radiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Overjet filed from Boston, Massachusetts. FDA found it substantially equivalent 128 calendar days after receipt (March 31 to August 6, 2026).
Clearance details
- Applicant
- Overjet, Inc.
- Product code
- Product code MYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.2070
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
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