# K102703: Build-IT Total Core

- Pathway: 510(k) (Traditional)
- Applicant: Pentron Clinical
- Decided: Jan 5, 2011 after 107 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K041474 (2004). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000211: Build-IT FR, Jeneric/Pentron, Inc. (2000) Summary page 1.
- K060698: Cement-IT All Purpose, Model N97, Pentron Clinical Technologies (2006) Summary page 1.

## Most influential descendants
- K153127: everX Posterior (2016), 1 descendant of its own
- K231263: Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT (2024), 0 descendants of its own
- K192260: everX Flow (2019), 0 descendants of its own

## Indications for use
Build-It Total Core is indicated for use as a core build up material on vital and non-vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material and dentin replacement material.

Source page: https://510kreport.com/device/K102703
Methodology: https://510kreport.com/methodology