# K103391: Ivobase Hybrid, Ivobase High Impact

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Feb 17, 2011 after 90 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K151142: Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid (2015), 14 descendants of its own
- K210977: E-Dent 1000 (2021), 7 descendants of its own
- K222623: Digital Crown (2022), 4 descendants of its own
- K230445: OnX Tough (2023), 2 descendants of its own
- K242277: Crown HT (2024), 1 descendant of its own

## Indications for use
IvoBase, Hybrid and Ivoase High Impact are intended for the fabrication of PMMA based acrylic dental prosthesis including but not limited to partial and full dentures.

Source page: https://510kreport.com/device/K103391
Methodology: https://510kreport.com/methodology