LogoFDA 510(k) Search
K Number
K251454

Validate with FDA (Live)

Device Name
Clear Aligner (SCF-3348)
Manufacturer
Beame Medical Technology (Shenzhen) Limited
Date Cleared
2026-01-07

(240 days)

Product Code
NXC
Regulation Number
872.5470
Type
Traditional
Panel
Dental
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.