K241568
- 510(k) number
- K241568
- Device name
- CrystLCare PRO Biorestorative, Fluoride-Plus
- Applicant
- GreenMark Biomedical, Inc. MI · US
- Product code
- LBH — Varnish, Cavity
- Decision date
- 2025-01-02
- Date received
- 2024-05-31
- 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: K241568.pdf
Official FDA record: K241568
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.