PERMA-CRYL 20— 510(k) K792427

Substantially Equivalent

Coe Laboratories, Inc.

FDA 510(k) clearance K792427 for PERMA-CRYL 20, Substantially Equivalent on 1979-12-13. Applicant: Coe Laboratories, Inc..

Clearance details

Applicant: Coe Laboratories, Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 1979-11-27
Decision date: 1979-12-13
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.