SELF-CURING HARD DENTURE LINER— 510(k) K820673

Substantially Equivalent

Coe Laboratories, Inc.

FDA 510(k) clearance K820673 for SELF-CURING HARD DENTURE LINER, Substantially Equivalent on 1982-04-09. Applicant: Coe Laboratories, Inc..

Clearance details

Applicant: Coe Laboratories, Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 1982-03-11
Decision date: 1982-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.