Byte Aligner System
K-Number: K230199 · 2023-10-18
ApplicantDentsply Sirona, Inc.
Decision Date2023-10-18
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Byte Aligner System is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2023-10-18 under approval number K230199. 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 2023-10-18. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K230199.
When was Byte Aligner System approved by the FDA?
Byte Aligner System received FDA 510(k) clearance on 2023-10-18, under approval number K230199.
What company makes Byte Aligner System?
Byte Aligner System is manufactured by Dentsply Sirona, Inc..
What is the FDA product code for Byte Aligner System?
The FDA product code for Byte Aligner System is NXC.
Related Clinical Trials
Other Devices by Dentsply Sirona, Inc.
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.