ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT— 510(k) K112138

Substantially Equivalent

Astra Tech, Inc.

FDA 510(k) clearance K112138 for ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT, Substantially Equivalent on 2011-12-01. Applicant: Astra Tech, Inc..

Clearance details

Applicant: Astra Tech, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 2011-07-26
Decision date: 2011-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, 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.