SmileSeries
K-Number: K221097 · 2022-07-14
Decision Date2022-07-14
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SmileSeries is a medical device manufactured by Ordont Orthodontic Laboratories, Inc.. It received FDA 510(k) clearance on 2022-07-14 under approval number K221097. 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 SmileSeries?
SmileSeries is a medical device that received FDA 510(k) clearance on 2022-07-14. It is manufactured by Ordont Orthodontic Laboratories, Inc.. The 510(k) number is K221097.
When was SmileSeries approved by the FDA?
SmileSeries received FDA 510(k) clearance on 2022-07-14, under approval number K221097.
What company makes SmileSeries?
SmileSeries is manufactured by Ordont Orthodontic Laboratories, Inc..
What is the FDA product code for SmileSeries?
The FDA product code for SmileSeries 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.