510(k) K191111— DD Solid Connect® CAD/CAM Abutments

Substantially Equivalent

Dental Direkt GmbH

Clearance details

Applicant: Dental Direkt GmbH
Product code: Code NHA
Advisory panel: Dental
Date received: 2019-04-26
Decision date: 2023-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spenge, DE

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.