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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 the device name listed in this FDA 510(k) record. The listed applicant is Denjoy Dental Co., Ltd.. It received FDA 510(k) clearance on 2025-02-13 under 510(k) 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. The listed applicant is Denjoy Dental Co., Ltd.. The 510(k) number is K242317.

When did Integrated Endo System (Meet Endo-II) receive FDA 510(k) clearance?

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

Who is the listed applicant for Integrated Endo System (Meet Endo-II)?

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

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.

Related Devices (Code: ELC)

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.

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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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