Implantswiss Dental Implant System, Implantswiss Dental Abutment System— 510(k) K181266

Substantially Equivalent

Novodent SA

FDA 510(k) clearance K181266 for Implantswiss Dental Implant System, Implantswiss Dental Abutment System, Substantially Equivalent on 2018-11-01. Applicant: Novodent SA.

Clearance details

Applicant: Novodent SA
Product code: Code DZE
Advisory panel: Dental
Date received: 2018-05-14
Decision date: 2018-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yverdons-Les-Bains, CH

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.