Clear Aligner (SCF-3348)

FDA 510(k) K251454 · Beame Medical Technology (Shenzhen) Limited

Substantially Equivalent

510(k) numberK251454

Submission

Device name
Clear Aligner (SCF-3348)
Applicant
Beame Medical Technology (Shenzhen) Limited
Shenzhen, CN
Received
May 12, 2025
Decision date
January 7, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NXC – Aligner, Sequential
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5470
Specialty
Dental

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

Other 510(k)s with product code NXC

510(k)DeviceApplicantDecision
K260527FACE4D AlignerNXC · Traditional Avinent Implant System S.L.U.07/02/2026SE
K260788Smylio AlignersNXC · Traditional Smylio, Inc.05/08/2026SE
K260722SureSmile Aligner (ASSY500020)NXC · Traditional Dentsply Sirona, Inc.04/15/2026SE
K253282ZSmile SystemNXC · Special Dror Orthodesign , Ltd.02/03/2026SE
K250739Primeprint Direct AlignerNXC · Traditional Dreve Dentamid GmbH11/07/2025SE
K252931Invisalign® Palatal Expander SystemNXC · Special Align Technology, Inc.10/23/2025SE
K252870Invisalign Specifix Attachment SystemNXC · Special Align Technology, Inc.10/09/2025SE
K251758Serafin®NXC · Traditional Tns Co., Ltd.09/11/2025SE
K252380Invisalign SystemNXC · Special Align Technology, Inc.08/29/2025SE
K251415Additively Manufactured Aligner ResinNXC · Traditional Aidite (Qinhuangdao) Technology Co., Ltd.08/27/2025SE

Questions and answers

When was Clear Aligner (SCF-3348) cleared by the FDA?

Clear Aligner (SCF-3348) (K251454) received a 510(k) decision of Substantially Equivalent on January 7, 2026, 240 days after the submission was received.

What is the product code of K251454?

The FDA product code is NXC – Aligner, Sequential, a Class II (moderate risk) device regulated under 21 CFR 872.5470.