# K912945: Satin Prophylaxis Paste

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Sep 16, 1991 after 73 days
- Product code: EJR (Agent, Polishing, Abrasive, Oral Cavity)
- Device class: 1
- Regulation: 21 CFR 872.6030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K033449: Pro-Dentec Double-Pro Prophylaxis Paste with Fluoide Family of Devices (2004), 1 descendant of its own
- K983966: Nupro Prophylaxis Paste with Flouride and Triclosan (1999), 1 descendant of its own
- K102053: Butler Calci-Flor Prophylaxis Paste (2011), 0 descendants of its own
- K100539: Preventech Prophylaxis Paste with Fluoride (2010), 0 descendants of its own
- K061427: Pre-Impression Conditioning Solution (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K912945
Methodology: https://510kreport.com/methodology