K254091
- 510(k) number
- K254091
- Device name
- GLOSSY COAT (15ML)
- Applicant
- YAMAHACHI DENTAL MFG., Co. JP
- Product code
- EBD — Coating, Filling Material, Resin
- Decision date
- 2026-04-06
- Date received
- 2025-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K254091.pdf
Official FDA record: K254091
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.