HYDROXI-FLEX IMPLANT— 510(k) K812321

Substantially Equivalent

Impladent

FDA 510(k) clearance K812321 for HYDROXI-FLEX IMPLANT, Substantially Equivalent on 1981-10-29. Applicant: Impladent.

Clearance details

Applicant: Impladent
Product code: Code DZE
Advisory panel: Dental
Date received: 1981-08-17
Decision date: 1981-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.