ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS— 510(k) K122268

Substantially Equivalent

Dentsply International

FDA 510(k) clearance K122268 for ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS, Substantially Equivalent on 2012-12-11. Applicant: Dentsply International.

Clearance details

Applicant: Dentsply International
Product code: Code NHA
Advisory panel: Dental
Date received: 2012-07-30
Decision date: 2012-12-11
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.