# K041371: Butler Nucare Prophylaxis Paste with Novamin

- Pathway: 510(k) (Traditional)
- Applicant: Novamin Technology, Inc.
- Decided: Aug 23, 2004 after 91 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
Longest line of descent: 2 generations back to K002989 (2000). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024343: Butler Gum Prophy Paste with Novamin, Usbiomaterials Corp. (2003) Summary page 1.

## Most influential descendants
- K062502: Osspray Cleaning Compound (2006), 2 descendants of its own
- K103114: Osspray Sylc CR (2011), 0 descendants of its own
- K100833: Syle Smartip (2010), 0 descendants of its own

## Indications for use
Butler NuCare Prophylaxis Paste with NovaMin is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. Secondarily, Butler NuCare Prophylaxis Paste with NovaMin can be used for the immediate relief of sensitivity, post-sealing and root planing.

Source page: https://510kreport.com/device/K041371
Methodology: https://510kreport.com/methodology