PROCERA ABUTMENT OCTAGON— 510(k) K041275

Substantially Equivalent

Nobel Biocare Uas, Inc.

FDA 510(k) clearance K041275 for PROCERA ABUTMENT OCTAGON, Substantially Equivalent on 2004-05-27. Applicant: Nobel Biocare Uas, Inc..

Clearance details

Applicant: Nobel Biocare Uas, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 2004-05-12
Decision date: 2004-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda,, CA, 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.