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FDA 510(k)

Integral Dental Units

K-Number: K242611 · 2025-05-27

ApplicantMipont Medical Equipment Co., Ltd.
Decision Date2025-05-27
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Integral Dental Units is the device name listed in this FDA 510(k) record. The listed applicant is Mipont Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-05-27 under 510(k) number K242611. 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 Integral Dental Units?

Integral Dental Units is a medical device that received FDA 510(k) clearance on 2025-05-27. The listed applicant is Mipont Medical Equipment Co., Ltd.. The 510(k) number is K242611.

When did Integral Dental Units receive FDA 510(k) clearance?

Integral Dental Units received FDA 510(k) clearance on 2025-05-27, under 510(k) number K242611.

Who is the listed applicant for Integral Dental Units?

The FDA 510(k) record lists Mipont Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Integral Dental Units?

The FDA product code for Integral Dental Units is EIA.

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.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus 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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