SYLE SMARTIP— 510(k) K100833

Substantially Equivalent

Osspray, Ltd.

FDA 510(k) clearance K100833 for SYLE SMARTIP, Substantially Equivalent on 2010-06-03. Applicant: Osspray, Ltd..

Clearance details

Applicant: Osspray, Ltd.
Product code: Code EFB
Advisory panel: Dental
Date received: 2010-03-24
Decision date: 2010-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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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.