Cleared Traditional

Midmark Dental Delivery System

K251626 · Midmark Corporation · Dental
Nov 2025
Decision
159d
Days
Class 1
Risk

About This 510(k) Submission

K251626 is an FDA 510(k) clearance for the Midmark Dental Delivery System, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Midmark Corporation (Versailles, US). The FDA issued a Cleared decision on November 3, 2025, 159 days after receiving the submission on May 28, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K251626 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2025
Decision Date November 03, 2025
Days to Decision 159 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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