BVR HIGH TORQUE HEADS— 510(k) K934781

Name: FDA 510(k) clearance K934781
Creator: U.S. Food and Drug Administration
Published: 1994-08-05

Substantially Equivalent

Bvr Aero Precision Corp.

FDA 510(k) clearance K934781 for BVR HIGH TORQUE HEADS, Substantially Equivalent on 1994-08-05. Applicant: Bvr Aero Precision Corp.. Device class: 1.

Clearance details

Applicant: Bvr Aero Precision Corp.
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 1993-10-05
Decision date: 1994-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockford, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

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.