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FDA 510(k)

Integrated Endo System (Meet Endo-II)

K-Number: K242317 · 2025-02-13

ApplicantDenjoy Dental Co., Ltd.
Decision Date2025-02-13
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Integrated Endo System (Meet Endo-II) is a medical device manufactured by Denjoy Dental Co., Ltd.. It received FDA 510(k) clearance on 2025-02-13 under approval number K242317. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Integrated Endo System (Meet Endo-II)?

Integrated Endo System (Meet Endo-II) is a medical device that received FDA 510(k) clearance on 2025-02-13. It is manufactured by Denjoy Dental Co., Ltd.. The 510(k) number is K242317.

When was Integrated Endo System (Meet Endo-II) approved by the FDA?

Integrated Endo System (Meet Endo-II) received FDA 510(k) clearance on 2025-02-13, under approval number K242317.

What company makes Integrated Endo System (Meet Endo-II)?

Integrated Endo System (Meet Endo-II) is manufactured by Denjoy Dental Co., Ltd..

What is the FDA product code for Integrated Endo System (Meet Endo-II)?

The FDA product code for Integrated Endo System (Meet Endo-II) is ELC.

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Related PubMed Literature

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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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