JUVORA Dental Disc, Ceramill PEEK by JUVORA— 510(k) K160918

Substantially Equivalent

Juvora

FDA 510(k) clearance K160918 for JUVORA Dental Disc, Ceramill PEEK by JUVORA, Substantially Equivalent on 2017-02-13. Applicant: Juvora.

Clearance details

Applicant: Juvora
Product code: Code EBI
Advisory panel: Dental
Date received: 2016-04-04
Decision date: 2017-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thornton-Clevelys, GB

Download summary PDF View on FDA.gov ↗

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.