Al Smile Aligner
K-Number: K222308 · 2022-12-20
Decision Date2022-12-20
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Al Smile Aligner is a medical device manufactured by Nanjing Jiahe Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-20 under approval number K222308. 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 Al Smile Aligner?
Al Smile Aligner is a medical device that received FDA 510(k) clearance on 2022-12-20. It is manufactured by Nanjing Jiahe Dental Technology Co., Ltd.. The 510(k) number is K222308.
When was Al Smile Aligner approved by the FDA?
Al Smile Aligner received FDA 510(k) clearance on 2022-12-20, under approval number K222308.
What company makes Al Smile Aligner?
Al Smile Aligner is manufactured by Nanjing Jiahe Dental Technology Co., Ltd..
What is the FDA product code for Al Smile Aligner?
The FDA product code for Al Smile Aligner is NXC.
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.