DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)— 510(k) K230218

Substantially Equivalent

Dental Direkt GmbH

FDA 510(k) clearance K230218 for DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series), Substantially Equivalent on 2023-04-25. Applicant: Dental Direkt GmbH.

Clearance details

Applicant: Dental Direkt GmbH
Product code: Code NHA
Advisory panel: Dental
Date received: 2023-01-26
Decision date: 2023-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spenge, DE

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.