EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM— 510(k) K861502

Substantially Equivalent

Dr. Harold Bergman

FDA 510(k) clearance K861502 for EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM, Substantially Equivalent on 1986-06-26. Applicant: Dr. Harold Bergman.

Clearance details

Applicant: Dr. Harold Bergman
Product code: Code DZE
Advisory panel: Dental
Date received: 1986-04-23
Decision date: 1986-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.