IMPLA-MED TITANIUM, IMPLANT DEVICES— 510(k) K900061

Substantially Equivalent

Impla-Med

FDA 510(k) clearance K900061 for IMPLA-MED TITANIUM, IMPLANT DEVICES, Substantially Equivalent on 1990-04-27. Applicant: Impla-Med.

Clearance details

Applicant: Impla-Med
Product code: Code DZE
Advisory panel: Dental
Date received: 1990-01-03
Decision date: 1990-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunrise, FL, US

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.