510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212519Substantially Equivalent

Overjet Caries Assist

Overjet, Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212519 is the FDA 510(k) clearance record for Overjet Caries Assist, a class II device, cleared for Overjet, Inc. on under FDA product code MYN (Analyzer, Medical Image). FDA's definition for product code MYN reads: "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". FDA records list 12 510(k) clearances for Overjet, Inc., from to . As of , FDA records show no recalls naming K212519.

Clearance record

Decision date
Received
(273 days to decision)
Product code
MYN Analyzer, Medical Image
Regulation
21 CFR 892.2070
Device class
Class II
Review panel
Radiology
Applicant
Overjet, Inc. 560 Harrison Ave., Unit 403, Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MYN

Trailing 12 months
10 clearances under product code MYN in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MYN, trailing twelve months
MonthClearances
November 20253
December 20250
January 20263
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20261
September 20261
October 20260