510(k) K091920— ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL

Substantially Equivalent

Astra Tech, Inc.

Clearance details

Applicant: Astra Tech, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 2009-06-30
Decision date: 2009-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, US

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.