S.I.N. Dental Implant System— 510(k) K222231

Substantially Equivalent

S.I.N. - Sistema DE Implante Nacional S.A.

FDA 510(k) clearance K222231 for S.I.N. Dental Implant System, Substantially Equivalent on 2022-10-27. Applicant: S.I.N. - Sistema DE Implante Nacional S.A..

Clearance details

Applicant: S.I.N. - Sistema DE Implante Nacional S.A.
Product code: Code DZE
Advisory panel: Dental
Date received: 2022-07-25
Decision date: 2022-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sao Paulo, BR

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.