# K043119: Amelogen Plus

- Pathway: 510(k) (Special)
- Applicant: Ultradent Products, Inc.
- Decided: Dec 17, 2004 after 37 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K201795: Transcend (2020), 1 descendant of its own
- K262228: Transcend Bulk Fill Flowable Composite (2026), 0 descendants of its own
- K052189: Reveneer Ceramic Repair System (2005), 0 descendants of its own

## Indications for use
The Amelogen plus is a tooth shade resin composite material [bisphenol-A, glycidyl methacrylate (Bis-GMA) based] to be used for posterior and anterior tooth restoration.

Source page: https://510kreport.com/device/K043119
Methodology: https://510kreport.com/methodology