PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS— 510(k) K061478

Substantially Equivalent

Nobel Biocare AB

FDA 510(k) clearance K061478 for PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS, Substantially Equivalent on 2006-08-21. Applicant: Nobel Biocare AB.

Clearance details

Applicant: Nobel Biocare AB
Product code: Code NHA
Advisory panel: Dental
Date received: 2006-05-30
Decision date: 2006-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda,, CA, 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.