Overjet Caries Assist
K222746Overjet, Inc. · cleared 2023-03-27 · product code MYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“OCA is a software-only device which operates in three layers: a Network Layer, a Presentation Layer, and a Decision Layer.”
source quote (p.4)
“Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Layer and results are pushed to the dashboard, which are in the Presentation Layer.Caries Module - This model segments carious lesions using an ensemble of 3 Instance Segmentation models.”
Validation studies (3)
Standalone
n=2,607 images
endpoints: Sensitivity; Specificity
standards: FDA Guidance for Industry and Food and Drug Administration Staff Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions Document, Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions
Bench
n=2,607 images
endpoints: Dice score
Reader study (MRMC)
n=660 images
endpoints: sensitivity; specificity; weighted alternative free response receiver operating characteristic (WAFROC)
standards: ISO 14971
Reported performance (12 observations)
source quote (p.9)
“For bitewing images, overall reader sensitivity improved from 64.6% (56.4%, 72.1%) to 78.5% (72.6%, 83.6%) unassisted vs assisted.”
source quote (p.10)
“For bitewing images, overall reader specificity decreased slightly from 99.0% (98.5%, 99.4%) to 98.6% (98.0%, 99.0%) unassisted vs assisted.”
source quote (p.11)
“On bitewing images, for the average of all readers, AUC increased from 0.729 (0.696, 0.761) to 0.785 (0.746, 0.822), for an increase in AUC of 0.055 (0.033, 0.079) unassisted to assisted.”
source quote (p.8)
“For bitewing images, overall standalone sensitivity was 76.6% (73.8%, 79.4%).”
source quote (p.8)
“Overall specificity was 99.1% (98.9%, 99.2%) for bitewing images”
source quote (p.8)
“For periapical images, overall standalone sensitivity was 79.4% (76.1%, 82.8%).”
source quote (p.8)
“and 99.4% (99.2%, 99.5%) for periapical images.”
source quote (p.10)
“For periapical images, overall reader sensitivity improved from 65.6% (59.4%, 71.7%) to 79.0% (73.0%, 84.7%) unassisted vs assisted.”
source quote (p.10)
“For periapical images, overall reader specificity decreased slightly from 98.0% (97.4%, 98.6%) to 97.6% (97.0%, 98.1%) unassisted vs assisted.”
source quote (p.11)
“On periapical images, for the average of all readers, AUC increased from 0.799 (0.764, 0.833) to 0.848 (0.814, 0.881), for an increase in AUC of 0.050 (0.031, 0.068) unassisted to assisted.”
source quote (p.10)
“On bitewing images, mean Dice scores increased from 0.67 (0.009 SD) to 0.76 (0.009 SD) for primary caries”
source quote (p.10)
“On periapical images, mean Dice scores increased from 0.73 (0.011 SD) to 0.80 (0.011 SD) for primary caries”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K233738 (decision 2024-03-04) from Overjet, Inc for a matching device line ("Overjet Caries Assist-Pediatric") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233738
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).