# K051931: AXCEL

- Pathway: 510(k) (Traditional)
- Applicant: Tri Dental Innovators
- Decided: Feb 17, 2006 after 219 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: 1 generation back to K920425 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K920425: 3M Brand Restorative Z100, 3M Company (1992) Summary page 1.
- K990898: Prodigy 4, Sybron Dental Specialties, Inc. (1999) Summary page 1.

## Most influential descendants
- K063714: Axcel Flow (2007), 0 descendants of its own

## Indications for use
For direct restorations, for use in all classes of cavities, including veneers and incisal edge repairs. For indirect anterior and posterior restorations, including inlays, onlays, and veneers.

Source page: https://510kreport.com/device/K051931
Methodology: https://510kreport.com/methodology