K250739
- 510(k) number
- K250739
- Device name
- Primeprint Direct Aligner
- Applicant
- Dreve Dentamid GmbH DE
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2025-11-07
- Date received
- 2025-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250739.pdf
Official FDA record: K250739
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.