JUELL HARD CURE— 510(k) K111177

Substantially Equivalent

Juell Dental

FDA 510(k) clearance K111177 for JUELL HARD CURE, Substantially Equivalent on 2011-09-12. Applicant: Juell Dental.

Clearance details

Applicant: Juell Dental
Product code: Code EBI
Advisory panel: Dental
Date received: 2011-04-27
Decision date: 2011-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ardmore, OK, 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.