Medentika CAD/CAM Abutments— 510(k) K242542

Name: FDA 510(k) clearance K242542
Creator: U.S. Food and Drug Administration
Published: 2025-04-22

Substantially Equivalent

Medentika GmbH

FDA 510(k) clearance K242542 for Medentika CAD/CAM Abutments, Substantially Equivalent on 2025-04-22. Applicant: Medentika GmbH. Device class: 2.

Clearance details

Applicant: Medentika GmbH
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2024-08-26
Decision date: 2025-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huegelsheim, DE

Download summary PDF View on FDA.gov ↗

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K253922 — Neodent Scannable Healing Abutment2026-06-15

More clearances from Medentika GmbH

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K253341 — Custom Abutments AS2025-12-23
K223113 — Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments2024-04-15
K201711 — CARES Screw - Retained Bars and Bridges (SRBB)2020-12-08
K200906 — MINICONE Implant2020-10-16
K191123 — Multi-unit Abutments2020-01-06

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.