K260819
- 510(k) number
- K260819
- Device name
- Any-Com Seal
- Applicant
- Mediclus Co., Ltd. KR
- Product code
- EBC — Sealant, Pit And Fissure, And Conditioner
- Decision date
- 2026-05-01
- Date received
- 2026-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260819.pdf
Official FDA record: K260819
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.