ASTRA TECH IMPLANT SYSTEM— 510(k) K111287

Substantially Equivalent

Astra Tech AB

FDA 510(k) clearance K111287 for ASTRA TECH IMPLANT SYSTEM, Substantially Equivalent on 2011-09-26. Applicant: Astra Tech AB.

Clearance details

Applicant: Astra Tech AB
Product code: Code DZE
Advisory panel: Dental
Date received: 2011-05-06
Decision date: 2011-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.