EXPANDED CLAIMES TO OSTEOGEN(R)— 510(k) K881662

Substantially Equivalent for Some Indications

Impladent

FDA 510(k) clearance K881662 for EXPANDED CLAIMES TO OSTEOGEN(R), Substantially Equivalent for Some Indications on 1988-09-01. Applicant: Impladent.

Clearance details

Applicant: Impladent
Product code: Code DZE
Advisory panel: Dental
Date received: 1988-04-15
Decision date: 1988-09-01
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Hollis, NY, US

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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.