# K253312: OrangeCAD Med Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Orangecad Med GmbH
- Decided: Dec 23, 2025 after 84 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 K960026 (1996). 317 ancestors in all.
No later device cites it as a predicate yet.
0 of 318 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170588: DESS Dental Smart Solutions, Terrats Medical SL (2017) Summary page 5.

## Indications for use
OrangeCAD Med Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. OrangeCAD Med Abutments are compatible with the following dental implant system: Compatibility Table Compatible Implant Systems: Straumann Bone Level Series: SM-BL Implant Body Diameter mm: 3.3; 4.1, 4.8 Implant Platform Diameter mm (name): 3.1 (NC); 3.7, 4.4 (RC)

Source page: https://510kreport.com/device/K253312
Methodology: https://510kreport.com/methodology