# K191382: IPS e.max CAD Abutment Solutions- extra systems

- Pathway: 510(k) (Abbreviated)
- Applicant: Ivoclar Vivadent, AG
- Decided: Aug 26, 2019 after 95 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: 12 generations back to K894844 (1990). 124 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132209: Ips E.Max Cad Abutment Solutions, Ivoclar Vivadent, AG (2013) Summary page 7.

## Most influential descendants
- K221402: CEREC Tessera Abutment Block, CEREC Tessera Abutment System (2023), 2 descendants of its own
- K252248: CEREC Tessera Abutment System (2025), 0 descendants of its own
- K234018: CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System (2024), 0 descendants of its own

## Indications for use
IPS e.max 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 ceramic structure - Ti base - CAD/CAM system. The IPS e.max CAD ceramic structure 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, titanium bases and CAD/CAM systems are shown below: -Implant Systems: - Dentsply Sirona: AstraTech OsseoSpeed, Frialit/Xive (K130999, K013867) - BioHorizons Implant System: Internal Connection (K143022, K071638, K093321, K042429), - Osstem: TS Implant System (K121585) - Straumann: Tissue Level RN/WN (K061176) - Nobel Biocare: Branemark (K022562) - Zimmer: Tapered Screw-Vent (K061410) - Camlog: Camlog Screw-Line, Conelog Screw-Line, iSy (K083496, K113779, K133991) - CAD/CAM Systems: Sirona Dental CAD/CAM System (K181520) -Titanium Bases:

Source page: https://510kreport.com/device/K191382
Methodology: https://510kreport.com/methodology