SuperLine
K-Number: K213599 · 2022-02-23
ApplicantDentium Co., Ltd.
Decision Date2022-02-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SuperLine is a medical device manufactured by Dentium Co., Ltd.. It received FDA 510(k) clearance on 2022-02-23 under approval number K213599. 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 SuperLine?
SuperLine is a medical device that received FDA 510(k) clearance on 2022-02-23. It is manufactured by Dentium Co., Ltd.. The 510(k) number is K213599.
When was SuperLine approved by the FDA?
SuperLine received FDA 510(k) clearance on 2022-02-23, under approval number K213599.
What company makes SuperLine?
SuperLine is manufactured by Dentium Co., Ltd..
What is the FDA product code for SuperLine?
The FDA product code for SuperLine 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.