K153546

Substantially Equivalent

PINK CAD/CAM disc

Applicant: Polident D.O.O., Dental Products Industry
Product code: EBI
Advisory panel: Dental
Date received: 2015-12-11
Decision date: 2016-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Volcja Draga, SI

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.