Custom-made Invisible Aligners
K-Number: K223454 · 2023-04-17
Decision Date2023-04-17
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Custom-made Invisible Aligners is a medical device manufactured by Zhejiang Yinchili Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-17 under approval number K223454. 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 Custom-made Invisible Aligners?
Custom-made Invisible Aligners is a medical device that received FDA 510(k) clearance on 2023-04-17. It is manufactured by Zhejiang Yinchili Medical Technology Co., Ltd.. The 510(k) number is K223454.
When was Custom-made Invisible Aligners approved by the FDA?
Custom-made Invisible Aligners received FDA 510(k) clearance on 2023-04-17, under approval number K223454.
What company makes Custom-made Invisible Aligners?
Custom-made Invisible Aligners is manufactured by Zhejiang Yinchili Medical Technology Co., Ltd..
What is the FDA product code for Custom-made Invisible Aligners?
The FDA product code for Custom-made Invisible Aligners is NXC.
Other Devices by Zhejiang Yinchili Medical Technology Co., Ltd.
Related Devices (Code: NXC)
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.