K232074

Serafin®

510(k) number
K232074
Device name
Serafin®
Applicant
Tns Co., Ltd. KR
Product code
NXC — Aligner, Sequential
Decision date
2024-02-22
Date received
2023-07-12
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K232074.pdf

Official FDA record: K232074
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.