# Medentika GmbH

- Location (FDA's records): Huegelsheim, DE
- FDA decisions: 10 (2015–2025): 10 510(k) clearances
- Product codes: NHA (9), DZE (1)
- 510(k) review time since 2016: median 216 days, against 156 for FDA's reviews in the same codes and years (3 of 8 faster)
- Predicates its devices cite: 33 (9 its own); citations of its devices by later devices: 26 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Institut Straumann AG: 4 (https://510kreport.com/company/institut-straumann)
- Nobel Biocare AB: 4 (https://510kreport.com/company/nobel-biocare)
- Implant Innovations, Inc.: 2 (https://510kreport.com/company/implant-innovations)
- Straumann USA: 2 (https://510kreport.com/company/straumann-usa)
- Astra Tech, Inc.: 2 (https://510kreport.com/company/astra-tech)
- Nobel Biocare Uas, Inc.: 1 (https://510kreport.com/company/nobel-biocare-uas)
- Zimmer Dental, Inc.: 1 (https://510kreport.com/company/zimmer-dental)
- Dentsply International, Inc.: 1 (https://510kreport.com/company/dentsply-international)

## Firms that cite its devices most
- Anthogyr: 2 (https://510kreport.com/company/anthogyr)
- Allonus Tech Co., Ltd.: 1 (https://510kreport.com/company/allonus-tech)
- Straumann USA: 1 (https://510kreport.com/company/straumann-usa)
- Mit Global Co., Ltd.: 1 (https://510kreport.com/company/mit-global)
- Dental Direkt GmbH: 1 (https://510kreport.com/company/dental-direkt)
- Bioclean Dental, LLC: 1 (https://510kreport.com/company/bioclean-dental)
- BioHorizons Implant Systems, Inc.: 1 (https://510kreport.com/company/biohorizons-implant-systems)
- Altatec GmbH: 1 (https://510kreport.com/company/altatec)

## Its most-cited devices
- K150203: Medentika CAD/CAM Abutments (2015), cited by 14
- K191123: Multi-unit Abutments (2020), cited by 4
- K223113: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments (2024), cited by 3
- K142167: Medentika Abutment System (2015), cited by 2
- K170838: Medentika CAD/CAM TiBases (2017), cited by 2
- K180564: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases (2019), cited by 1

## Recent decisions
- K253341: Custom Abutments AS (Dec 23, 2025)
- K242542: Medentika CAD/CAM Abutments (Apr 22, 2025)
- K223113: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments (Apr 15, 2024)
- K201711: CARES Screw - Retained Bars and Bridges (SRBB) (Dec 8, 2020)
- K200906: MINICONE Implant (Oct 16, 2020)
- K191123: Multi-unit Abutments (Jan 6, 2020)
- K180564: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases (Jan 7, 2019)
- K170838: Medentika CAD/CAM TiBases (Sep 15, 2017)

Source page: https://510kreport.com/company/medentika