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FDA 510(k)

Dentis s-Clean s-Line Mini

K-Number: K210080 · 2021-06-04

Decision Date2021-06-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentis s-Clean s-Line Mini is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2021-06-04 under approval number K210080. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dentis s-Clean s-Line Mini?

Dentis s-Clean s-Line Mini is a medical device that received FDA 510(k) clearance on 2021-06-04. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K210080.

When was Dentis s-Clean s-Line Mini approved by the FDA?

Dentis s-Clean s-Line Mini received FDA 510(k) clearance on 2021-06-04, under approval number K210080.

What company makes Dentis s-Clean s-Line Mini?

Dentis s-Clean s-Line Mini is manufactured by Dentis Co., Ltd..

What is the FDA product code for Dentis s-Clean s-Line Mini?

The FDA product code for Dentis s-Clean s-Line Mini is DZE.

Other Devices by Dentis Co., Ltd.

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Related Devices (Code: DZE)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.