IMPACT AIR 45 4-HOLE— 510(k) K952927

Substantially Equivalent

Palisades Pharmaceutics, Inc.

FDA 510(k) clearance K952927 for IMPACT AIR 45 4-HOLE, Substantially Equivalent on 1996-08-06. Applicant: Palisades Pharmaceutics, Inc..

Clearance details

Applicant: Palisades Pharmaceutics, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 1995-06-26
Decision date: 1996-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tenafly, NJ, US

Download summary PDF View on FDA.gov ↗

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.