Medentika GmbH is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Medentika GmbH - FDA 510(k) Cleared Devices
Recent clearances: Custom Abutments AS, Medentika CAD/CAM Abutments, Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
10
Total
10
Cleared
0
Denied
Medentika GmbH has 10 FDA 510(k) cleared dental devices. Based in San Diego, US.
Latest FDA clearance: Dec 2025. Active since 2015.
Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Straumann USA, LLC and PaxMed International, LLC.
FDA 510(k) Regulatory Record - Medentika GmbH
10 devices
Cleared
Dec 23, 2025
Custom Abutments AS
Dental
84d
Cleared
Apr 22, 2025
Medentika CAD/CAM Abutments
Dental
239d
Cleared
Apr 15, 2024
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM...
Dental
560d
Cleared
Dec 08, 2020
CARES Screw - Retained Bars and Bridges (SRBB)
Dental
168d
Cleared
Oct 16, 2020
MINICONE Implant
Dental
193d
Cleared
Jan 06, 2020
Multi-unit Abutments
Dental
252d
Cleared
Jan 07, 2019
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM...
Dental
308d
Cleared
Sep 15, 2017
Medentika CAD/CAM TiBases
Dental
178d
Cleared
Oct 23, 2015
Medentika CAD/CAM Abutments
Dental
267d
Cleared
Feb 20, 2015
MEDENTIKA ABUTMENT SYSTEM
Dental
198d