Cleared Traditional

Serafin?

K232074 · Tns Co., Ltd. · Dental
Feb 2024
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K232074 is an FDA 510(k) clearance for the Serafin?, a Aligner, Sequential (Class II — Special Controls, product code NXC), submitted by Tns Co., Ltd. (Geumcheon-Gu, KR). The FDA issued a Cleared decision on February 22, 2024, 225 days after receiving the submission on July 12, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K232074 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2023
Decision Date February 22, 2024
Days to Decision 225 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.