Implance Dental Implant System, Implance Dental Abutment System— 510(k) K160221

Substantially Equivalent

Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.

FDA 510(k) clearance K160221 for Implance Dental Implant System, Implance Dental Abutment System, Substantially Equivalent on 2016-09-12. Applicant: Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti..

Clearance details

Applicant: Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.
Product code: Code DZE
Advisory panel: Dental
Date received: 2016-01-29
Decision date: 2016-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Istanbul, TR

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.