# K990898: Prodigy 4

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Apr 6, 1999 after 19 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Prodigy: named in the summary without a submission number
- (no number) Heliomolar: named in the summary without a submission number

## Most influential descendants
- K051931: AXCEL (2006), 1 descendant of its own
- K063714: Axcel Flow (2007), 0 descendants of its own

## Indications for use
Prodigy 4 is a dental composite restorative material intended to be used in all classes of cavities.

Source page: https://510kreport.com/device/K990898
Methodology: https://510kreport.com/methodology