K251415
- 510(k) number
- K251415
- Device name
- Additively Manufactured Aligner Resin
- Applicant
- Aidite (Qinhuangdao) Technology Co., Ltd. CN
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2025-08-27
- Date received
- 2025-05-07
- 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: K251415.pdf
Official FDA record: K251415
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.