# Dental Direkt GmbH

- Location (FDA's records): Spenge, DE
- FDA decisions: 9 (2015–2024): 9 510(k) clearances
- Product codes: EIH (5), NHA (2), EBI (1), EBG (1)
- 510(k) review time since 2016: median 121 days, against 147 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 8 (3 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
- Dental Direkt of Amerika UG (Haftungsbeschraenkt): 2 (https://510kreport.com/company/dental-direkt-of-amerika-ug-haftungsbeschraenkt)
- Medentika GmbH: 1 (https://510kreport.com/company/medentika)
- Union Dental S.A.: 1 (https://510kreport.com/company/union-dental)
- Jensen Industries, Inc.: 1 (https://510kreport.com/company/jensen-industries)

## Firms that cite its devices most
- Doctus Global: 1 (https://510kreport.com/company/doctus-global)
- Ams: 1 (https://510kreport.com/company/ams)
- H.C. Starck Ceramics GmbH: 1 (https://510kreport.com/company/hc-starck-ceramics)
- Dentalmax Co., Ltd.: 1 (https://510kreport.com/company/dentalmax)
- Adamant Co., Ltd.: 1 (https://510kreport.com/company/adamant)

## Its most-cited devices
- K150196: DD cubeX2 (2015), cited by 4
- K170885: DD cubeX2 HS (2017), cited by 1
- K191111: DD Solid Connect® CAD/CAM Abutments (2023), cited by 1
- K153490: DD medical polymers (2016), cited by 1
- K193588: DD Contrast (2020), cited by 1

## Recent decisions
- K241579: DD Hybridlayer (multicolored zirconia) (Sep 6, 2024)
- K230410: DD medical polymers (PMMA) (Jun 23, 2023)
- K230218: DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) (Apr 25, 2023)
- K191111: DD Solid Connect® CAD/CAM Abutments (Jan 11, 2023)
- K193588: DD Contrast (Apr 16, 2020)
- K183569: DD cube ONE ML (Feb 14, 2019)
- K170885: DD cubeX2 HS (Aug 1, 2017)
- K153490: DD medical polymers (May 13, 2016)

Source page: https://510kreport.com/company/dental-direkt