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Radiology · 510(k) · 2023

Overjet Caries Assist

Overjet, Inc.. Cleared by FDA on 27 March 2023 under submission K222746, product code MYN (analyzer, medical image). What FDA's record says, in FDA's words.

Device record · K222746

  1. Device. Overjet Caries AssistDEVICE
  2. Company. Overjet, Inc.COMPANY
  3. Decision. 27 March 2023, 510(k), substantially equivalent (traditional review); received 12 September 2022DECISION
  4. Panel. RadiologyPANEL
  5. Product code. MYN, Analyzer, Medical ImageCODE
  6. Regulation. 21 CFR 892.2070, Class IIREG
  7. Source. FDA database entry · decision document (12 pages)SOURCE

Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.

What FDA cleared it for

The Indications for Use statement, verbatim, from the decision document.

Overjet Caries Assist (OCA) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment.

K222746, FDA decision document · source

The product code's definition, from FDA's classification record. 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

What the statement says

Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.

Adverse-event reports in MAUDE, by product code

As of , MAUDE held 5 reports filed against devices carrying product code MYN. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:

13 March 2025 · Injury · SECOND OPINION · PEARL INC. · report MW5167620

DEAR FDA MEDWATCH, I AM REPORTING A SERIOUS ISSUE REGARDING PLANET DDS'S INTEGRATION OF PEARL AI ASSIST IN DENTICON PMS AND XVWEB IMAGING SYSTEM, WHICH LED TO AN INACCURATE TREATMENT RECOMMENDATION AND INABILITY TO CORRECT AI FINDINGS. WHAT HAPPENED I RECENTLY VISITED A DENTAL CLINIC THAT USES DENTICON PMS WITH PEARL AI ASSIST. BEFORE REVIEWING MY DENTAL IMAGES, THE DENTIST RECOMMENDED AN ENDODONTIC PROCEDURE BASED ON AI FINDINGS DISPLAYED IN DENTICON. AI SUGGESTED DECAY AND A PERIAPICAL […]

18 February 2025 · Malfunction · OVERJET CARIES ASSIST · OVERJET · report MW5166306

THE 510(K) SUBSTANTIAL EQUIVALENCE REPORT FOR OVERJET CARIES ASSIST (K212519) SHOWS SENSITIVITY AND SPECIFICITY OF 72.0% AND 98.1%, RESPECTIVELY, FOR CARIES DETECTION. HOWEVER, CALCULATIONS BASED ON THE TABLE IN SECTION 10 REVEAL A POSITIVE PREDICTIVE VALUE OF ONLY 57.2%. THIS MEANS THAT 42.8% OF OBSERVED CARIES BY THE OVERJET PRODUCT WERE NOT ACTUALLY CARIES ACCORDING TO GROUND TRUTH. SUCH A HIGH RATE OF FALSE POSITIVES HAS THE POTENTIAL TO RESULT IN OVER-TREATMENT DUE TO FALSELY IDENTIFYING […]

15 April 2024 · Malfunction · PEARL SECOND OPINION · PEARL INC. · report MW5153880

HELLO, I AM WRITING TO EXPRESS SIGNIFICANT CONCERNS REGARDING THE COMPLIANCE AND MARKETING PRACTICES OF PEARL, PARTICULARLY RELATED TO THEIR DENTAL DIAGNOSTIC TOOLS. OUR EXPECTATIONS WERE THAT PEARL'S FDA CLEARED MEDICAL DEVICE ((B)(6)) WOULD ADHERE TO THE HIGHEST STANDARDS OF REGULATORY COMPLIANCE, ESPECIALLY GIVEN THE CRITICAL NATURE OF DENTAL HEALTH DIAGNOSTICS. HOWEVER, IT APPEARS THERE ARE CRUCIAL AREAS WHERE PEARL'S OFFERINGS MAY NOT ALIGN WITH REGULATORY GUIDELINES AND DO NOT ALIGN WITH […]

11 January 2018 · Malfunction · POWERLOOK AMP WITH SECONDLOOK DIGITAL GE · ICAD, INCORPORATED · report 1225671-2018-00001

A CUSTOMER SITE INDICATED THAT NO CAD MARKINGS WERE REPORTED FROM THE CAD AFTER PROCESSING PATIENT IMAGES. THE OEM MAMMOGRAPHY FIELD SERVICE ENGINEER (FSE) DID NOT APPLY THE CAD LICENSE AFTER INSTALLING THE CAD SOFTWARE. THIS RESULTED IN THE SITE NOT HAVING CAD MARKS ON CASES FOR SOME TIME. NO PATIENT INJURY OR ADVERSE EVENT WAS ASSOCIATED WITH THIS INCIDENT.

18 May 2006 · Malfunction · RAPIDSCREEN RS-2000D AND RS-DIGITAL · RIVERAIN MEDICAL · report 3005156333-2006-00001

ON APRIL 24, 2006, A CONTROL FILE ERROR WITH RESPECT TO THE RAPIDSCREEN RS-2000D AND RS-DIGITAL DEVICE WAS DISCOVERED DURING A CLINICAL STUDY BEING CONDUCTED FOR A PMA SUPPLEMENTAL SUBMISSION. THE CONTROL FILE ERROR RESULTS IN SENSITIVITY AND SPECIFICITY THAT DIFFER FROM THE PMA-APPROVED PRODUCT SPECIFICATIONS FOR THE DEVICE. SPECIFICALLY, THE PRODUCT THAT WAS PLACED INTO COMMERCIAL DISTRIBUTION HAS A SENSITIVITY OF 57% AND A SPECIFICITY OF 3.97 (FALSE POSITIVES PER IMAGE), WHICH DIFFERS FROM […]

Where this fits

This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.

More devices under product code MYN, in Radiology, from Overjet, Inc., or cleared in 2023. The whole record is at FDA AI-enabled medical devices.

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