510(k) K212519

Overjet Caries Assist by Overjet, Inc. — Product Code MYN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 10, 2022
Date Received: August 10, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Analyzer, Medical Image
Device Class: Class II
Regulation Number: 892.2070
Review Panel: RA
Submission Type

For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers

Other clearances by Overjet, Inc.

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K233738 — Overjet Caries Assist-Pediatric (March 4, 2024)
K233590 — Overjet Charting Assist (February 23, 2024)
K231678 — Overjet Periapical Radiolucency Assist (September 21, 2023)
K222746 — Overjet Caries Assist (March 27, 2023)
K220928 — Overjet Calculus Assist (December 16, 2022)
K210187 — Overjet Dental Assist (May 19, 2021)

Other clearances for product code MYN

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K253009 — DS Core Detect (January 7, 2026)
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K250525 — Second Opinion® Panoramic (November 14, 2025)
K250264 — SugarBug (1.x) (November 7, 2025)
K251002 — Videa Dental AI (September 19, 2025)
K250753 — VELMENI for DENTISTS (V4D) (September 2, 2025)
K243234 — Second Opinion® CS (June 12, 2025)
K242437 — Smile Dx® (May 14, 2025)