# K181520: Sirona Dental CAD/CAM System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Oct 11, 2018 after 122 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: 11 generations back to K894844 (1990). 120 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111421: Sirona Dental Cad/Cam System, Sirona Dental Systems GmbH (2012) Summary page 6.

## Most influential descendants
- K193408: Sirona Dental CAD/CAM System with CEREC Chairside Software (2020), 2 descendants of its own
- K191152: MIS Ti-base Abutment (2020), 1 descendant of its own
- K250295: Dentsply Sirona Titanium Bases system (2025), 0 descendants of its own
- K233285: KATANA Zirconia ONE For IMPLANT (2024), 0 descendants of its own
- K211225: MIS Ti-base abutment (2021), 0 descendants of its own

## Indications for use
The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the BH 3.0 S, SSO 3.5 L and S%L 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system consists of three major parts: TiBase, inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems:

Source page: https://510kreport.com/device/K181520
Methodology: https://510kreport.com/methodology