Nucleoss T6 Dental Implant System— 510(k) K192062

Substantially Equivalent

Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST

FDA 510(k) clearance K192062 for Nucleoss T6 Dental Implant System, Substantially Equivalent on 2020-08-27. Applicant: Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST.

Clearance details

Applicant: Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST
Product code: Code DZE
Advisory panel: Dental
Date received: 2019-08-01
Decision date: 2020-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Izmir, 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.