ISUS IMPLANT SUPRASTRUCTURES— 510(k) K122424

Substantially Equivalent

Dentsply International, Inc.

FDA 510(k) clearance K122424 for ISUS IMPLANT SUPRASTRUCTURES, Substantially Equivalent on 2013-07-05. Applicant: Dentsply International, Inc..

Clearance details

Applicant: Dentsply International, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 2012-08-09
Decision date: 2013-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.