ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT— 510(k) K101005

Substantially Equivalent

Astra Tech AB

FDA 510(k) clearance K101005 for ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT, Substantially Equivalent on 2011-06-21. Applicant: Astra Tech AB.

Clearance details

Applicant: Astra Tech AB
Product code: Code NHA
Advisory panel: Dental
Date received: 2010-04-12
Decision date: 2011-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, 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.