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FDA 510(k)

Integral Dental Unit

K-Number: K243130 · 2025-06-27

ApplicantGuangdong Yadeng Medical Apparatus Co., Ltd.,
Decision Date2025-06-27
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Integral Dental Unit is a medical device manufactured by Guangdong Yadeng Medical Apparatus Co., Ltd.,. It received FDA 510(k) clearance on 2025-06-27 under approval number K243130. 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 Unit?

Integral Dental Unit is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Guangdong Yadeng Medical Apparatus Co., Ltd.,. The 510(k) number is K243130.

When was Integral Dental Unit approved by the FDA?

Integral Dental Unit received FDA 510(k) clearance on 2025-06-27, under approval number K243130.

What company makes Integral Dental Unit?

Integral Dental Unit is manufactured by Guangdong Yadeng Medical Apparatus Co., Ltd.,.

What is the FDA product code for Integral Dental Unit?

The FDA product code for Integral Dental Unit 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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