# K150432: Idodentine Disc, Idodentine Block

- Pathway: 510(k) (Traditional)
- Applicant: Union Dental S.A.
- Decided: Aug 14, 2015 after 176 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K924830 (1994). 4 ancestors in all.
23 later devices descend from it; 6 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071548: Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored, Merz Dental GmbH (2007) Summary page 4.

## Most influential descendants
- K190107: VeriSplint (2019), 10 descendants of its own
- K203000: KeyPrint KeySplint Hard (2021), 6 descendants of its own
- K180578: Harvest Dental Polymer Blocks (2018), 3 descendants of its own
- K211415: GR Splint Resin System (2021), 2 descendants of its own
- K201173: E-Guard (2020), 2 descendants of its own

## Indications for use
Acrylic polymer blank particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM. Indications: - Temporary anterior and posterior crowns - Temporary anterior and posterior bridges with up to two adjacent pontics - Implant supported temporary restorations Maximum recommended usage period: 12 months - Removable structures for dentures (dental bases) - Removable structures for therapeutic restorations (bite splints or occlusal splints)

Source page: https://510kreport.com/device/K150432
Methodology: https://510kreport.com/methodology