CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO— 510(k) K000834

Substantially Equivalent

Castellini S.P.A.

FDA 510(k) clearance K000834 for CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO, Substantially Equivalent on 2000-12-14. Applicant: Castellini S.P.A..

Clearance details

Applicant: Castellini S.P.A.
Product code: Code EFB
Advisory panel: Dental
Date received: 2000-03-14
Decision date: 2000-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel Maggiore, Bologna, IT

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Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.