# K200191: Sirona Dental CAD/CAM System with InLab Software

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Aug 19, 2020 after 205 days
- Product code: PNP (Dental Abutment Design Software For Dental Laboratory)
- 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 K894844 (1990). 121 ancestors in all.
No later device cites it as a predicate yet.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181520: Sirona Dental CAD/CAM System, Dentsply Sirona (2018) Summary page 6.

## Indications for use
The Sirona Dental CAD/CAM System with InLab Software 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 SBL 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/K200191
Methodology: https://510kreport.com/methodology