IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE— 510(k) K972375

Substantially Equivalent

Glenwood, LLC

FDA 510(k) clearance K972375 for IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE, Substantially Equivalent on 1997-09-10. Applicant: Glenwood, LLC.

Clearance details

Applicant: Glenwood, LLC
Product code: Code EFB
Advisory panel: Dental
Date received: 1997-06-25
Decision date: 1997-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, 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.