Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments— 510(k) K223113

Name: FDA 510(k) clearance K223113
Creator: U.S. Food and Drug Administration
Published: 2024-04-15

Substantially Equivalent

Medentika GmbH

FDA 510(k) clearance K223113 for Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments, Substantially Equivalent on 2024-04-15. 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: 2022-10-03
Decision date: 2024-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hugelsheim, DE

Download summary PDF View on FDA.gov ↗

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K261147 — Neodent Implant System - NeoConvert Fit2026-07-01
K261122 — MIST IC2026-06-27
K260061 — BioHorizons CEREC Compatible Ti-Bases2026-06-26
K253922 — Neodent Scannable Healing Abutment2026-06-15

More clearances from Medentika GmbH

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K253341 — Custom Abutments AS2025-12-23
K242542 — Medentika CAD/CAM Abutments2025-04-22
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.