Cleared Traditional

Overjet Caries Assist (K212519) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212519 · Overjet, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
273d
Days
Class 2
Risk

K212519 is an FDA 510(k) clearance for the Overjet Caries Assist. Classified as Analyzer, Medical Image (product code MYN), Class II - Special Controls.

Submitted by Overjet, Inc. (Boston, US). The FDA issued a Cleared decision on May 10, 2022 after a review of 273 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2070 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Overjet, Inc. devices

Submission Details

510(k) Number K212519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2021
Decision Date May 10, 2022
Days to Decision 273 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 107d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MYN Analyzer, Medical Image
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2070
Definition 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 this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MYN Analyzer, Medical Image

All 36
Devices cleared under the same product code (MYN) and FDA review panel - the closest regulatory comparables to K212519.
Overjet Caries Assist
K222746 · Overjet, Inc. · Mar 2023
Overjet Calculus Assist
K220928 · Overjet, Inc. · Dec 2022
Aorta-CAD
K213353 · Imagen Technologies, Inc. · Sep 2022
Videa Caries Assist
K213795 · Videahealth, Inc. · Apr 2022
Second Opinion
K210365 · Pearl, Inc. · Mar 2022
Auto Lung Nodule Detection
K201560 · Samsung Electronics Co., Ltd. · Aug 2021