K982593

Substantially Equivalent

LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE

Applicant: Dentalez Group
Product code: EFB
Advisory panel: Dental
Date received: 1998-07-24
Decision date: 1998-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lancaster, PA, 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.