K233935
- 510(k) number
- K233935
- Device name
- DigiLine Direct Print Aligner System
- Applicant
- Park Dental Research Corporation OK · US
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2024-04-05
- Date received
- 2023-12-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K233935.pdf
Official FDA record: K233935
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.