IPS E.MAX CAD ABUTMENT SOLUTIONS— 510(k) K132209

Substantially Equivalent

Ivoclar Vivadent, AG

FDA 510(k) clearance K132209 for IPS E.MAX CAD ABUTMENT SOLUTIONS, Substantially Equivalent on 2013-10-31. Applicant: Ivoclar Vivadent, AG.

Clearance details

Applicant: Ivoclar Vivadent, AG
Product code: Code NHA
Advisory panel: Dental
Date received: 2013-07-16
Decision date: 2013-10-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Amherst, NY, US

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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.