JBC OPAQUE AND GLITTER— 510(k) K002048

Substantially Equivalent

J.B.C and Co.

FDA 510(k) clearance K002048 for JBC OPAQUE AND GLITTER, Substantially Equivalent on 2000-08-30. Applicant: J.B.C and Co..

Clearance details

Applicant: J.B.C and Co.
Product code: Code EBI
Advisory panel: Dental
Date received: 2000-06-26
Decision date: 2000-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, 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.