U-Aligner
K-Number: K191308 · 2020-04-23
Decision Date2020-04-23
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
U-Aligner is a medical device manufactured by Universal Orthodontic Laboratory, Inc.. It received FDA 510(k) clearance on 2020-04-23 under approval number K191308. 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 U-Aligner?
U-Aligner is a medical device that received FDA 510(k) clearance on 2020-04-23. It is manufactured by Universal Orthodontic Laboratory, Inc.. The 510(k) number is K191308.
When was U-Aligner approved by the FDA?
U-Aligner received FDA 510(k) clearance on 2020-04-23, under approval number K191308.
What company makes U-Aligner?
U-Aligner is manufactured by Universal Orthodontic Laboratory, Inc..
What is the FDA product code for U-Aligner?
The FDA product code for U-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.