MONOSTERYL— 510(k) K926205

Substantially Equivalent

Utensili Super Abrasivi

FDA 510(k) clearance K926205 for MONOSTERYL, Substantially Equivalent on 1994-02-10. Applicant: Utensili Super Abrasivi.

Clearance details

Applicant: Utensili Super Abrasivi
Product code: Code EJL
Advisory panel: Dental
Date received: 1992-12-09
Decision date: 1994-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: (Milan), Italy, IT

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Adverse events under product code EJL

product code EJL

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.