ORL-E-92 SURGICAL DRILL SYSTEM— 510(k) K984244

Substantially Equivalent

Bien Air USA, Inc.

FDA 510(k) clearance K984244 for ORL-E-92 SURGICAL DRILL SYSTEM, Substantially Equivalent on 1999-02-23. Applicant: Bien Air USA, Inc..

Clearance details

Applicant: Bien Air USA, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 1998-11-27
Decision date: 1999-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.