Cleared Traditional

MESHEET

K233544 · Dentis Co., Ltd. · Dental
Feb 2024
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K233544 is an FDA 510(k) clearance for the MESHEET, a Aligner, Sequential (Class II — Special Controls, product code NXC), submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on February 22, 2024, 111 days after receiving the submission on November 3, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K233544 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2023
Decision Date February 22, 2024
Days to Decision 111 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.