K233768
- 510(k) number
- K233768
- Device name
- Papacarie Duo
- Applicant
- Elevate Oral Care FL · US
- Product code
- LBH — Varnish, Cavity
- Decision date
- 2024-07-18
- Date received
- 2023-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233768.pdf
Official FDA record: K233768
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.