K232222
- 510(k) number
- K232222
- Device name
- Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
- Applicant
- Medency S.R.L. IT
- Product code
- NVK — Laser, Dental, Soft Tissue
- Decision date
- 2023-11-27
- Date received
- 2023-07-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K232222.pdf
Official FDA record: K232222
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.