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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 the device name listed in this FDA 510(k) record. The listed applicant is Midmark Corporation. It received FDA 510(k) clearance on 2025-11-03 under 510(k) 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. The listed applicant is Midmark Corporation. The 510(k) number is K251626.

When did Midmark Dental Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for Midmark Dental Delivery System?

The FDA 510(k) record lists Midmark Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Midmark Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerK201667Midmark Extraoral Imaging System (EOIS)K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerK161909IQvitals Zone

Related Devices (Code: EIA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLCK242404BDC Dental UnitBdc Dental Corporation , Ltd.

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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