# K193193: Telio CAD Abutment Solutions- extra systems

- Pathway: 510(k) (Abbreviated)
- Applicant: Ivoclar Vivadent, AG
- Decided: Nov 16, 2020 after 363 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: 14 generations back to K894844 (1990). 179 ancestors in all.
No later device cites it as a predicate yet.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151564: Telio CAD Abutment Solutions, Ivoclar Vivadent, AG (2015) Summary page 7.

## Indications for use
Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months). The system comprises three parts: - Telio CAD Abutment Solutions - Ti base and (Dentsply Sirona K181520, Camlog K083496, Conelog K143337, iSy K133991) - CAD/CAM software: Sirona Dental CAD/CAM System (K100152, K111521, K181520) Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants. The compatible implant systems, CAD/CAM systems and Ti bases are shown below: -Implant systems: The Telio CAD PMMA structure and TiBase hybrid abutment is compatible with the following implant systems: – AstraTech Osseospeed (Dentsply Sirona K130999, K091239) – Frialit/Xive (Dentsply Sirona K013867)) – internal connection (BioHorizons K143022, K071638, K093321, K042429) – Replace (Nobel Biocare K020646) – Nobel Active (Nobel Biocare K071370) – Bränemark® (Nobel Biocare K022562) – Tissue Level (Straumann K061176) – Tapered Screw-Vent (Zimmer K061410) – Camlog Screw-Line (Camlog K083496) – Conelog Screw-Line (Camlog K113779) – iSy (Camlog K133991) – Osstem TS (Osstem (USA: Hiossen) K121585) For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single laterial incisors in the maxilla and lateral and central incisors in the mandible.

Source page: https://510kreport.com/device/K193193
Methodology: https://510kreport.com/methodology