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The Tracker / November 2025 / K251626

510(k) cleared

Midmark Dental Delivery System

Midmark Corporation · Nov 3, 2025 · K251626

FDA cleared the Midmark Dental Delivery System from Midmark Corporation on Nov 3, 2025 under K251626, a traditional 510(k). The device falls under product code EIA, Unit, Operative Dental, regulated at 21 CFR 872.6640 as a Class 1 device. The review panel was Dental.

FDA logged the submission as received on May 28, 2025. The decision came 159 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Midmark Corporation has one other decision in the tracker over the last 12 months: K253196 (Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)).

Questions & Answers

What did FDA clear under K251626?

K251626 is the FDA 510(k) for Midmark Dental Delivery System, submitted by Midmark Corporation. FDA's decision date was Nov 3, 2025, under product code EIA (Unit, Operative Dental).

Who makes the Midmark Dental Delivery System?

Midmark Corporation, based in Versailles, OH, is the applicant of record for K251626.

How long did the K251626 review take?

FDA received the submission on May 28, 2025 and issued its decision on Nov 3, 2025, 159 days later.

← All decisions in November 2025

Sources