K230199
- 510(k) number
- K230199
- Device name
- Byte Aligner System
- Applicant
- Dentsply Sirona, Inc. PA · US
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2023-10-18
- Date received
- 2023-01-25
- 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: K230199.pdf
Official FDA record: K230199
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.