OSTEOMED IB DRILL— 510(k) K911937

Substantially Equivalent

Osteomed Corp.

FDA 510(k) clearance K911937 for OSTEOMED IB DRILL, Substantially Equivalent on 1991-06-10. Applicant: Osteomed Corp..

Clearance details

Applicant: Osteomed Corp.
Product code: Code EFB
Advisory panel: Dental
Date received: 1991-05-01
Decision date: 1991-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, 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.