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FDA 510(k)

Dentis i-Clean System

K-Number: K230307 · 2023-07-11

ApplicantDentis Co., Ltd.
Decision Date2023-07-11
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentis i-Clean System is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2023-07-11 under approval number K230307. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dentis i-Clean System?

Dentis i-Clean System is a medical device that received FDA 510(k) clearance on 2023-07-11. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K230307.

When was Dentis i-Clean System approved by the FDA?

Dentis i-Clean System received FDA 510(k) clearance on 2023-07-11, under approval number K230307.

What company makes Dentis i-Clean System?

Dentis i-Clean System is manufactured by Dentis Co., Ltd..

What is the FDA product code for Dentis i-Clean System?

The FDA product code for Dentis i-Clean System is NHA.

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Other Devices by Dentis Co., Ltd.

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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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