K260569
- 510(k) number
- K260569
- Device name
- DB 4000 High Impact Denture Base
- Applicant
- Carbon, Inc. CA · US
- Product code
- EBI — Resin, Denture, Relining, Repairing, Rebasing
- Decision date
- 2026-06-02
- Date received
- 2026-02-19
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260569.pdf
Official FDA record: K260569
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.