DB 4000 High Impact Denture Base— 510(k) K260569

Substantially Equivalent

Carbon, Inc.

FDA 510(k) clearance K260569 for DB 4000 High Impact Denture Base, Substantially Equivalent on 2026-06-02. Applicant: Carbon, Inc..

Clearance details

Applicant: Carbon, Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 2026-02-19
Decision date: 2026-06-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.