IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE— 510(k) K124008

Substantially Equivalent

Ivoclar Vivadent, Agin

FDA 510(k) clearance K124008 for IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE, Substantially Equivalent on 2013-03-29. Applicant: Ivoclar Vivadent, Agin.

Clearance details

Applicant: Ivoclar Vivadent, Agin
Product code: Code NHA
Advisory panel: Dental
Date received: 2012-12-27
Decision date: 2013-03-29
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.