ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT— 510(k) K093780

Substantially Equivalent

Astra Tech, Inc.

FDA 510(k) clearance K093780 for ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT, Substantially Equivalent on 2010-04-16. Applicant: Astra Tech, Inc..

Clearance details

Applicant: Astra Tech, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 2009-12-09
Decision date: 2010-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, 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.