# K122295: Core 3D Abutment System for Digital Prosthetic Solutions

- Pathway: 510(k) (Abbreviated)
- Applicant: Core 3D Protech, S.L.
- Decided: Oct 24, 2013 after 450 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: 13 generations back to K960026 (1996). 192 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 222 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111935: TI-Base Abutment, 1 Connect Abutment, Nt-Trading GmbH and CO KG (2012) Summary page 1.
- K103291: Biohorizons Laser-Lok Abutments for Nobel Biocare, BioHorizons Implant Systems, Inc. (2011) Summary page 1.
- K083192: Inclusive Titanium Abutment Blanks, Inclusive Dental Solutions (2009) Summary page 1.
- K062493: Lava Software, 3M Espe AG Dental Products (2006) Summary page 1.

## Most influential descendants
- K151621: BioHorizons CAD/CAM Abutments (2016), 26 descendants of its own
- K183518: Preat Abutments (2019), 22 descendants of its own
- K193096: S.I.N. Dental Implant System (2020), 8 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K211921: S.I.N. Dental Implant System (2021), 5 descendants of its own

## Indications for use
The CORE 3D abutment system for digital prosthetic solutions are dental abutments placed into a dental implant to provide support for dental prosthetic restorations. The abutments include: - Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment; - Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; - Abutment Screws to permanently fix the abutments to the underlying implant. Core 3D abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations. Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3D allowable range of design specifications and be provided as straight abutments only. Core 3D abutments and are compatible for use with the following dental implants: * Nobel Biocare Brånemark System (K022582, K934825) * Zimmer Tapered Screwvent (K013227, K061410, K072589)

Source page: https://510kreport.com/device/K122295
Methodology: https://510kreport.com/methodology