COMFORTSOFT SOFT DENTURE LINER SYSTEM— 510(k) K140146

Substantially Equivalent

Whip Mix Corp.

FDA 510(k) clearance K140146 for COMFORTSOFT SOFT DENTURE LINER SYSTEM, Substantially Equivalent on 2014-04-29. Applicant: Whip Mix Corp..

Clearance details

Applicant: Whip Mix Corp.
Product code: Code EBI
Advisory panel: Dental
Date received: 2014-01-22
Decision date: 2014-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

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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.