# K222581: Stela Automix System

- Pathway: 510(k) (Traditional)
- Applicant: Sdi Limited
- Decided: Oct 28, 2022 after 63 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: 7 generations back to K900510 (1990). 39 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053040: Paracem Universal DC, Coltene/Whaledent AG (2005) Summary page 5.
- K110302: Adhesive Exl-759, 3M Espe AG (2011) Summary page 5.
- K150218: Fill-Up!, Coltene/Whaledent AG (2015) Summary page 5.
- K083610: Filtek Supreme Ultra Universal Restorative, 3M Company (2008) Summary page 5.

## Most influential descendants
- K242097: DenMat Bulk Fill Composite (2024), 0 descendants of its own

## Indications for use
Stela Primer: - Dentin and enamel bonding Stela Automix: - Direct Class I, 11, Il and V cavities. Ideally Class I and 11. - Base or liner - Core build-ups.

Source page: https://510kreport.com/device/K222581
Methodology: https://510kreport.com/methodology