Custom Abutments AS— 510(k) K253341

Substantially Equivalent

Medentika GmbH

FDA 510(k) clearance K253341 for Custom Abutments AS, Substantially Equivalent on 2025-12-23. Applicant: Medentika GmbH.

Clearance details

Applicant: Medentika GmbH
Product code: Code NHA
Advisory panel: Dental
Date received: 2025-09-30
Decision date: 2025-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huegelsheim, 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.