Neodent Implant System - Zirconia Implant System— 510(k) K222026

Substantially Equivalent

Jjgc Industria E Comercio DE Materiais Dentarios S.A.

FDA 510(k) clearance K222026 for Neodent Implant System - Zirconia Implant System, Substantially Equivalent on 2023-07-14. Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A..

Clearance details

Applicant
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Product code
Code NHA
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Curitiba, BR
Download summary PDFView on FDA.gov ↗

Adverse events under product code NHA

product code NHA
Injury
1,270
Malfunction
2,860
Total
4,130

Source: openFDA MAUDE database, through . 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.