# K113738: Creodent Solidex Custom Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Creodent Prosthetics, Ltd.
- Decided: Sep 17, 2013 after 637 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: 9 generations back to K894595 (1990). 76 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091026: TDS Abutment for Nobel Biocare Replace, Pou YU Biotechnology Co., Ltd. (2009) Summary page 2.
- K091756: Nobelprocera TI Abutment, Nobel Biocare AB (2009) Summary page 4.
- K071439: Zimmer Patient-Specific Abutment, Internal Hex, Titanium, Zimmer Dental, Inc. (2007) Summary page 2.

## Most influential descendants
- K150012: CreoDent Solidex Customized Abutment (2015), 6 descendants of its own
- K162734: CreoDent Solidex Customized Abutment (2017), 1 descendant of its own
- K220390: CreoDent Solidex Customized Abutment and Screw (2022), 0 descendants of its own
- K202909: CreoDent Solidex Customized Abutment (2021), 0 descendants of its own
- K202095: CreoDent Solidex Customized Abutment and Screw (2020), 0 descendants of its own

## Indications for use
The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following: * Nobel Replace TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants * Nobel Active Internal Connection 3.5mm and 4.3mm diameter Implants * Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and 6.0mm diameter Implants

Source page: https://510kreport.com/device/K113738
Methodology: https://510kreport.com/methodology