QuickAligners
K-Number: K211537 · 2021-10-26
ApplicantOral Image, Inc.
Decision Date2021-10-26
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
QuickAligners is a medical device manufactured by Oral Image, Inc.. It received FDA 510(k) clearance on 2021-10-26 under approval number K211537. 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 QuickAligners?
QuickAligners is a medical device that received FDA 510(k) clearance on 2021-10-26. It is manufactured by Oral Image, Inc.. The 510(k) number is K211537.
When was QuickAligners approved by the FDA?
QuickAligners received FDA 510(k) clearance on 2021-10-26, under approval number K211537.
What company makes QuickAligners?
QuickAligners is manufactured by Oral Image, Inc..
What is the FDA product code for QuickAligners?
The FDA product code for QuickAligners 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.