# K063714: Axcel Flow

- Pathway: 510(k) (Traditional)
- Applicant: Tri Dental Innovators
- Decided: Jan 31, 2007 after 48 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: 2 generations back to K920425 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051931: AXCEL, Tri Dental Innovators (2006) Summary page 1.
- K013647: Revolution Formula 2, Sybron Dental Specialties, Inc. (2002) Summary page 1.

## Indications for use
Restoration of minimally invasive cavity preparations (including occusal pits and fissures) Conservative anterior restorations (Classes III and IV) Base/liner under direct restorations Repair of fillings and veneers

Source page: https://510kreport.com/device/K063714
Methodology: https://510kreport.com/methodology