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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 a medical device manufactured by Mipont Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-05-27 under approval 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. It is manufactured by Mipont Medical Equipment Co., Ltd.. The 510(k) number is K242611.

When was Integral Dental Units approved by the FDA?

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

What company makes Integral Dental Units?

Integral Dental Units is manufactured by Mipont Medical Equipment Co., Ltd..

What is the FDA product code for Integral Dental Units?

The FDA product code for Integral Dental Units is EIA.

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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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