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FDA 510(k)

Midmark Dental Delivery System

K-Number: K251626 · 2025-11-03

ApplicantMidmark Corporation
Decision Date2025-11-03
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Midmark Dental Delivery System is a medical device manufactured by Midmark Corporation. It received FDA 510(k) clearance on 2025-11-03 under approval number K251626. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Midmark Dental Delivery System?

Midmark Dental Delivery System is a medical device that received FDA 510(k) clearance on 2025-11-03. It is manufactured by Midmark Corporation. The 510(k) number is K251626.

When was Midmark Dental Delivery System approved by the FDA?

Midmark Dental Delivery System received FDA 510(k) clearance on 2025-11-03, under approval number K251626.

What company makes Midmark Dental Delivery System?

Midmark Dental Delivery System is manufactured by Midmark Corporation.

What is the FDA product code for Midmark Dental Delivery System?

The FDA product code for Midmark Dental Delivery System is EIA.

Related Clinical Trials

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Related PubMed Literature

PMID: 40774046 Strengthening Dental Materiovigilance: A Review of International Reporting Frameworks. International dental journal (2025)

Other Devices by Midmark Corporation

K161909IQvitals Zone K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer K201667Midmark Extraoral Imaging System (EOIS) K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer

Related Devices (Code: EIA)

K161734Vanguard Dental UnitRitter Concept GmbH K161488ESTETICA Dental Treatment Unit and AccessoriesKaltenbach & Voigt GmbH K151996TAURUS C1Shinhung Company, Ltd. K152100Evogue Dental UnitTakara Belmont Corporation K152830K3Osstem Implant Co., Ltd. K173608Forest Dental UnitForest Dental Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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