Cleared Traditional

Serafin?

K251758 · Tns Co., Ltd. · Dental

Sep 2025

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K251758 is an FDA 510(k) clearance for the Serafin?, a Aligner, Sequential (Class II — Special Controls, product code NXC), submitted by Tns Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on September 11, 2025, 94 days after receiving the submission on June 9, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K251758 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2025
Decision Date	September 11, 2025
Days to Decision	94 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.