K243254
- 510(k) number
- K243254
- Device name
- Parkell Pit and Fissure Sealant
- Applicant
- Parkell, Inc. NJ · US
- Product code
- EBC — Sealant, Pit And Fissure, And Conditioner
- Decision date
- 2025-08-08
- Date received
- 2024-10-15
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243254.pdf
Official FDA record: K243254
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.