# K191111: DD Solid Connect® CAD/CAM Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Dental Direkt GmbH
- Decided: Jan 11, 2023 after 1,356 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K894844 (1990). 262 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 264 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180564: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika GmbH (2019) Summary page 4.

## Most influential descendants
- K230218: DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) (2023), 0 descendants of its own

## Indications for use
DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. All digitally designed custom abutments for use with DD Solid Connect® CAD/CAM Abutments are to be sent to a Dental Direkt validated milling center for manufacture. DD Prefab abutments, for the Zimmer Biomet 3i Certain 3.4mm implant bodies, and DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, are indicated for maxillary lateral and mandibular central/lateral incisors only. Compatible Implant Systems: Manufacturer Implant System Diameter (mm) - Altatech Camlog 3.3, 3.8, 4.3, 5.0 - Nobel Biocare Nobel Active 3.5, 4.3/5.0 - Nobel Biocare Replace Select Tapered 3.5, 4.3, 5.0 - Dentsply Implants AstraTech OsseoSpeed 3.5/4.1, 4.5/5.0 - Straumann Bone Level 3.3, 4.1/4.8 - Straumann SynOcta 4.8, 6.5 - Zimmer Dental Tapered Screw-Vent 3.5, 4.5, 5.7 - Dentsply Implants Xive 3.4, 3.8, 4.5, 5.5 - Dentsply Implants Astra EV 3.6, 4.2, 4.8, 5.4 - Zimmer Biomet 3i Certain 3.4, 4.1/5.0

Source page: https://510kreport.com/device/K191111
Methodology: https://510kreport.com/methodology