Cleared Traditional

Byte Aligner System

K230199 · Dentsply Sirona, Inc. · Dental
Oct 2023
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K230199 is an FDA 510(k) clearance for the Byte Aligner System, a Aligner, Sequential (Class II — Special Controls, product code NXC), submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on October 18, 2023, 266 days after receiving the submission on January 25, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K230199 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2023
Decision Date October 18, 2023
Days to Decision 266 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NXC — Aligner, Sequential
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.