Dentis s-Clean s-Line
K-Number: K210134 · 2021-04-19
ApplicantDentis Co., Ltd.
Decision Date2021-04-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dentis s-Clean s-Line is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2021-04-19 under approval number K210134. 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?
Dentis s-Clean s-Line is a medical device that received FDA 510(k) clearance on 2021-04-19. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K210134.
When was Dentis s-Clean s-Line approved by the FDA?
Dentis s-Clean s-Line received FDA 510(k) clearance on 2021-04-19, under approval number K210134.
What company makes Dentis s-Clean s-Line?
Dentis s-Clean s-Line is manufactured by Dentis Co., Ltd..
What is the FDA product code for Dentis s-Clean s-Line?
The FDA product code for Dentis s-Clean s-Line is DZE.
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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.