Cleared Traditional

Clear Aligner (SCF-3348)

K251454 · Beame Medical Technology (Shenzhen) Limited · Dental

Jan 2026

Decision

240d

Days

Class 2

Risk

About This 510(k) Submission

K251454 is an FDA 510(k) clearance for the Clear Aligner (SCF-3348), a Aligner, Sequential (Class II — Special Controls, product code NXC), submitted by Beame Medical Technology (Shenzhen) Limited (Shenzhen, CN). The FDA issued a Cleared decision on January 7, 2026, 240 days after receiving the submission on May 12, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K251454 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2025
Decision Date	January 07, 2026
Days to Decision	240 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.