AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV— 510(k) K043497

Substantially Equivalent

J. Morita USA, Inc.

FDA 510(k) clearance K043497 for AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV, Substantially Equivalent on 2005-03-21. Applicant: J. Morita USA, Inc..

Clearance details

Applicant: J. Morita USA, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2004-12-17
Decision date: 2005-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.