# K230218: DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)

- Pathway: 510(k) (Traditional)
- Applicant: Dental Direkt GmbH
- Decided: Apr 25, 2023 after 89 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: 17 generations back to K894844 (1990). 263 ancestors in all.
No later device cites it as a predicate yet.
0 of 264 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191111: DD Solid Connect® CAD/CAM Abutments, Dental Direkt GmbH (2023) Summary page 4.

## Indications for use
DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, Dentsply Implants Astra Tech OsseoSpeed 3.5mm implant bodies, Dentsply Implants Xive 3.4mm implant bodies, Straumann Bone Level 3.3mm implant bodies, Zimmer Biomet 3i Certain 3.4mm implant bodies and Zimmer Dental Tapered Screw-Vent 3.5mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. All digitally designed custom abutments for use with DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are to be sent to a Dental Direkt validated milling center for manufacture. Compatible Implant Systems: - 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: Xive (3.4, 3.8, 4.5, 5.5) - 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: Astra Tech OsseoSpeed (3.5/4.0, 4.5/5.0) - 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/K230218
Methodology: https://510kreport.com/methodology