Clear Aligners
K-Number: K210373 · 2021-08-27
Decision Date2021-08-27
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Clear Aligners is a medical device manufactured by Shenzhen Yinuo Dental Technology Co.Ltd. It received FDA 510(k) clearance on 2021-08-27 under approval number K210373. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Clear Aligners?
Clear Aligners is a medical device that received FDA 510(k) clearance on 2021-08-27. It is manufactured by Shenzhen Yinuo Dental Technology Co.Ltd. The 510(k) number is K210373.
When was Clear Aligners approved by the FDA?
Clear Aligners received FDA 510(k) clearance on 2021-08-27, under approval number K210373.
What company makes Clear Aligners?
Clear Aligners is manufactured by Shenzhen Yinuo Dental Technology Co.Ltd.
What is the FDA product code for Clear Aligners?
The FDA product code for Clear Aligners is NXC.
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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.