UniSmile Clear Aligner System
K-Number: K191837 · 2020-01-29
ApplicantVitang Technology, LLC
Decision Date2020-01-29
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
UniSmile Clear Aligner System is a medical device manufactured by Vitang Technology, LLC. It received FDA 510(k) clearance on 2020-01-29 under approval number K191837. 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 UniSmile Clear Aligner System?
UniSmile Clear Aligner System is a medical device that received FDA 510(k) clearance on 2020-01-29. It is manufactured by Vitang Technology, LLC. The 510(k) number is K191837.
When was UniSmile Clear Aligner System approved by the FDA?
UniSmile Clear Aligner System received FDA 510(k) clearance on 2020-01-29, under approval number K191837.
What company makes UniSmile Clear Aligner System?
UniSmile Clear Aligner System is manufactured by Vitang Technology, LLC.
What is the FDA product code for UniSmile Clear Aligner System?
The FDA product code for UniSmile Clear Aligner System is NXC.
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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.