# K151150: Elements

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent International, Inc.
- Decided: Jul 28, 2015 after 89 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K091613 (2009). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091613: TAKE 1, Kerr Corp. (2009) Summary page 4.

## Most influential descendants
- K223892: DentMix VPS Impression Material (2023), 2 descendants of its own
- K254152: Dia-X Sil Light Body (2026), 0 descendants of its own
- K254142: Dia-X Sil Heavy Body (2026), 0 descendants of its own

## Indications for use
Elements™ is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient’s teeth and gums.

Source page: https://510kreport.com/device/K151150
Methodology: https://510kreport.com/methodology