# K202909: CreoDent Solidex Customized Abutment

- Pathway: 510(k) (Special)
- Applicant: Creodent Prosthetics, Ltd.
- Decided: Apr 2, 2021 after 185 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: 12 generations back to K894595 (1990). 79 ancestors in all.
No later device cites it as a predicate yet.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162734: CreoDent Solidex Customized Abutment, Creodent Prosthetics, Ltd. (2017) Summary page 5.

## Indications for use
The CreoDent Solidex® Customized Abutment and screw 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 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 dental implants: Manufacturer Implant Line Platform Implant Body Diameter (mm) Diameter (mm) Altatec Biotechnolgies N.A. Incorporated Camlog Screwline Implant Promote 3.3 3.3 Altatec Biotechnolgies N.A. Incorporated Camlog Screwline Implant Promote 3.8 3.8 Altatec Biotechnolgies N.A. Incorporated Camlog Screwline Implant Promote 4.3 4.3 Altatec Biotechnolgies N.A. Incorporated Camlog Screwline Implant Promote 5.0 5.0 Astra Tech, Inc Osseospeed TX Implants 3.5 3.5 Astra Tech, Inc Osseospeed TX Implants 4.5 4.5 Biomet 3i Osseotite Certain Dental Implants 3.4 3.25 Biomet 3i Osseotite Certain Dental Implants 4.1 4.0 Biomet 3i Osseotite Certain Dental Implants 5.0 5.0 Biomet 3i Osseotite Certain Dental Implants 6.0 6.0 Dentium CO., Ltd Dentium 3.6mm Implantium 3.6 3.4 Hiossen Hiossen TS Implants 3.5 (Mini) 3.5 Hiossen Hiossen TS Implants 4.0 (Regular) 4.0 Lifecore Biomedical, Inc PrimaConnex Implants Internal (KeyStone) 3.5 2.4 Lifecore Biomedical, Inc PrimaConnex Implants Internal (KeyStone) 4.1 2.7 Lifecore Biomedical, Inc PrimaConnex Implants Internal (KeyStone) 5.0 3.3 Nobel Biocare NobelActiveTM Internal Connection Implant 3.5 (NP) 3.5 Nobel Biocare NobelActiveTM Internal Connection Implant 3.9 (RP) 4.3 Nobel Biocare NobelReplaceTM TiUnite Endosseous Implant 3.5 (NP) 3.5 Nobel Biocare NobelReplaceTM TiUnite Endosseous Implant 4.3, 5.0 (RP) 4.3, 5.0 Thommen Medical AG SPI Element Dental Implants RC INCELL PF 3.5 3.5 Thommen Medical AG SPI Element Dental Implants RC INCELL PF 4.0 4.0 Thommen Medical AG SPI Element Dental Implants RC INCELL PF 4.5 4.2 Thommen Medical AG SPI Element Dental Implants RC INCELL PF 5.0 5.0 Thommen Medical AG SPI Element Dental Implants RC INCELL PF 6.0 6.0 Straumann Straumann Bone Level (BL) Implants 3.3 (NC) 3.3 Straumann Straumann Bone Level (BL) Implants 4.1, 4.8 (RC) 4.1, 4.8 Zimmer Zimmer Screw-Vent, Tapered Screw-Vent Implant 3.5 3.7 Zimmer Zimmer Screw-Vent, Tapered Screw-Vent Implant 4.5 4.7 Zimmer Zimmer Tapered Screw-Vent Implant 5.7 6.0 All digitally designed files for CreoDent Solidex@ Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture.

Source page: https://510kreport.com/device/K202909
Methodology: https://510kreport.com/methodology