DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER— 510(k) K881245

Name: FDA 510(k) clearance K881245
Creator: U.S. Food and Drug Administration
Published: 1988-07-21

Substantially Equivalent

Cadco Dental Products, Inc.

FDA 510(k) clearance K881245 for DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER, Substantially Equivalent on 1988-07-21. Applicant: Cadco Dental Products, Inc.. Device class: 2.

Clearance details

Applicant: Cadco Dental Products, Inc.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 1988-03-23
Decision date: 1988-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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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.