# K100152: Sirona Cad/Cam System

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Oct 22, 2010 after 276 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: 9 generations back to K894844 (1990). 115 ancestors in all.
240 later devices descend from it; 5 cite it directly.
0 of 356 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.
- K032448: Altatec Ceramic Abutment, Altatec Biotechnologies (2003) Summary page 1.
- K062493: Lava Software, 3M Espe AG Dental Products (2006) Summary page 1.

## Most influential descendants
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST (2012), 165 descendants of its own
- K150203: Medentika CAD/CAM Abutments (2015), 129 descendants of its own
- K150367: Neodent Implant System (2015), 89 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K111421: Sirona Dental Cad/Cam System (2012), 54 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 implants systems: * Nobel Biocare Replace (K020646) * Nobel Biocare Branemark (K022562) * FriadentXive (K013867) * Biomet 3i Osseotite (K980549) * Astra Tech Osseospeed (K091239) * Zimmer Tapered Screw-Vent (K061410) * Straumann SynOcta (K061176)

Source page: https://510kreport.com/device/K100152
Methodology: https://510kreport.com/methodology