# K132209: Ips E.Max Cad Abutment Solutions

- Pathway: 510(k) (Abbreviated)
- Applicant: Ivoclar Vivadent, AG
- Decided: Oct 31, 2013 after 107 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). 123 ancestors in all.
39 later devices descend from it; 5 cite it directly.
0 of 163 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)
- K051705: Ips E.Max Cad/Ips E.Max Zircad, Ivoclar Vivadent, Inc. (2005) Summary page 1.
- K120053: Ips E.Max Press - Abutment Solutions, Ivoclar Vivadent, AG (2012) Summary page 1.
- K124008: Ips E. Max Press Abutment Solutions for Nobel Biocare, Ivoclar Vivadent, Agin (2013) Summary page 1.

## Most influential descendants
- 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
- K162890: BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment (2017), 5 descendants of its own

## Indications for use
IPS emax CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts: IPS e.max CAD mesostructure, Ti base and CAD/CAM software. The IPS e.max CAD mesostructure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants. The compatible Implant systems, Ti bases and CAD/CAM systems are shown below: Implant systems: Nobel Biocare Replace (K020646), Nobel Biocare Activemn (K071370), Straumann Bone Level (K053088, K062129, K060958), Biomet 3i Osseotite (K980549) CAD/CAM Systems: Sirona inLab and Cerec SW 4.2 and above Titanium bases: Implant Implant System - Implant TIBase * Sirona' Interface manufacturer Diameter Ref. size Nobel Biocare Replace NP 3.5 NBRS 3.5 6282474 L _______Replace RP 4.3 NBRS 4.3 6282482 L Replace WVP 5.0 NBRS 5.0 6282490 L _______Replace 6.0 6.0 NBRS 6.0 6282508 L Nobel Biocare Nobel Active NP 3.5 NB A 4.5 6208188 L Nobel Active RP I______ 4.3/5.0 1NB A 5.0 16208253 L Straumann Bone Level NC 3.3 S BL 3.3 6308154 L ______Bone Level RC 4.1/4.8 88L 4.1 6308337 L Biomet 3i Certain 3.4 BC 3.4 6308048 S _______Certain 4.1 B 04.1 6305097 L _______Certain 5.0 BC 5.0 16308121 L For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

Source page: https://510kreport.com/device/K132209
Methodology: https://510kreport.com/methodology