# K111421: Sirona Dental Cad/Cam System

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Feb 17, 2012 after 273 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: 10 generations back to K894844 (1990). 119 ancestors in all.
54 later devices descend from it; 7 cite it directly.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091756: Nobelprocera TI Abutment, Nobel Biocare AB (2009) Summary page 1.
- K081005: P.004 NC Cares Titanium and Ceramic Abutments, Institut Straumann AG (2008) Summary page 1.
- K081666: Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 Implants, Astra Tech, Inc. (2008) Summary page 1.
- K032158: Xive Dental Implant System Multiple, Friadent GmbH (2003) Summary page 1.
- K072642: Biomet 3I Dental Abutments and Restorative Components, Biomet 3i, Inc. (2007) Summary page 1.
- K060880: Zimmer Dental One Piece Tapered Abutment, Models TAC1, TACW1, TA5C1, Zimmer Dental, Inc. (2006) Summary page 1.
- K102436: Nobel Active 3.0, Nobel Biocare AB (2010) Summary page 1.
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 1.
- K073345: Certain Contoured Margin Ceramic Abutment, Biomet 3i, Inc. (2008) Summary page 1.
- K100152: Sirona Cad/Cam System, Sirona Dental Systems GmbH (2010) Summary page 12.

## Most influential descendants
- K132209: Ips E.Max Cad Abutment Solutions (2013), 39 descendants of its own
- K142890: Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit (2015), 30 descendants of its own
- K151324: Straumann Variobase for CEREC (2015), 13 descendants of its own
- K171532: TruBase S (2018), 7 descendants of its own
- K201197: TruAbutment DS, TruBase S (2021), 6 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. 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: * Nobel Biocare Replace (K020646) * Nobel Biocare Branemark (K022562) * Friadent Xive (K013867) * Biomet 3i Osseotite (K980549) * Astra Tech Osseospeed (K091239) * Zimmer Tapered Screw-Vent (K061410) * Straumann SynOcta (K061176) * Straumann Bone Level (K053088) * Biomet 3i Certain (K014235) * Nobel Biocare Active (K071370)

Source page: https://510kreport.com/device/K111421
Methodology: https://510kreport.com/methodology