Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System— 510(k) K180184

Substantially Equivalent

Dentalpoint AG

FDA 510(k) clearance K180184 for Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System, Substantially Equivalent on 2018-11-16. Applicant: Dentalpoint AG.

Clearance details

Applicant: Dentalpoint AG
Product code: Code NHA
Advisory panel: Dental
Date received: 2018-01-23
Decision date: 2018-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spreitenbach, CH

Download summary PDF View 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, 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.