LUXEN CL Dental Liquid
K-Number: K212548 · 2021-12-06
ApplicantDentalmax Co., Ltd.
Decision Date2021-12-06
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
LUXEN CL Dental Liquid is a medical device manufactured by Dentalmax Co., Ltd.. It received FDA 510(k) clearance on 2021-12-06 under approval number K212548. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LUXEN CL Dental Liquid?
LUXEN CL Dental Liquid is a medical device that received FDA 510(k) clearance on 2021-12-06. It is manufactured by Dentalmax Co., Ltd.. The 510(k) number is K212548.
When was LUXEN CL Dental Liquid approved by the FDA?
LUXEN CL Dental Liquid received FDA 510(k) clearance on 2021-12-06, under approval number K212548.
What company makes LUXEN CL Dental Liquid?
LUXEN CL Dental Liquid is manufactured by Dentalmax Co., Ltd..
What is the FDA product code for LUXEN CL Dental Liquid?
The FDA product code for LUXEN CL Dental Liquid is EIH.
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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.