DEFEND Ear-loop Face Masks
K-Number: K201127 · 2021-04-14
Decision Date2021-04-14
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DEFEND Ear-loop Face Masks is a medical device manufactured by Young Dental Manufacturing Co. 1, LLC. It received FDA 510(k) clearance on 2021-04-14 under approval number K201127. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DEFEND Ear-loop Face Masks?
DEFEND Ear-loop Face Masks is a medical device that received FDA 510(k) clearance on 2021-04-14. It is manufactured by Young Dental Manufacturing Co. 1, LLC. The 510(k) number is K201127.
When was DEFEND Ear-loop Face Masks approved by the FDA?
DEFEND Ear-loop Face Masks received FDA 510(k) clearance on 2021-04-14, under approval number K201127.
What company makes DEFEND Ear-loop Face Masks?
DEFEND Ear-loop Face Masks is manufactured by Young Dental Manufacturing Co. 1, LLC.
What is the FDA product code for DEFEND Ear-loop Face Masks?
The FDA product code for DEFEND Ear-loop Face Masks is FXX.
Other Devices by Young Dental Manufacturing Co. 1, LLC
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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.