# K010267: Palfique Estelite LV Clear

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama America, Inc.
- Decided: Feb 27, 2001 after 29 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
No predicates in its family tree.
4 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K173275: Omnichroma (2018), 3 descendants of its own
- K193537: Omnichroma Flow (2020), 1 descendant of its own
- K261071: DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) (2026), 0 descendants of its own
- K203598: Omnichroma Flow Bulk (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K010267
Methodology: https://510kreport.com/methodology