Toothsi, Smilealigners
K-Number: K223338 · 2023-02-09
Decision Date2023-02-09
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Toothsi, Smilealigners is a medical device manufactured by Makeo Healthcare Technologies Private Limited. It received FDA 510(k) clearance on 2023-02-09 under approval number K223338. 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 Toothsi, Smilealigners?
Toothsi, Smilealigners is a medical device that received FDA 510(k) clearance on 2023-02-09. It is manufactured by Makeo Healthcare Technologies Private Limited. The 510(k) number is K223338.
When was Toothsi, Smilealigners approved by the FDA?
Toothsi, Smilealigners received FDA 510(k) clearance on 2023-02-09, under approval number K223338.
What company makes Toothsi, Smilealigners?
Toothsi, Smilealigners is manufactured by Makeo Healthcare Technologies Private Limited.
What is the FDA product code for Toothsi, Smilealigners?
The FDA product code for Toothsi, Smilealigners 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.