Byte Aligner System
K-Number: K180346 · 2019-02-19
ApplicantStraight Smile, LLC
Decision Date2019-02-19
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Byte Aligner System is a medical device manufactured by Straight Smile, LLC. It received FDA 510(k) clearance on 2019-02-19 under approval number K180346. 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 Byte Aligner System?
Byte Aligner System is a medical device that received FDA 510(k) clearance on 2019-02-19. It is manufactured by Straight Smile, LLC. The 510(k) number is K180346.
When was Byte Aligner System approved by the FDA?
Byte Aligner System received FDA 510(k) clearance on 2019-02-19, under approval number K180346.
What company makes Byte Aligner System?
Byte Aligner System is manufactured by Straight Smile, LLC.
What is the FDA product code for Byte Aligner System?
The FDA product code for Byte Aligner System is NXC.
Related Clinical Trials
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.