# K024343: Butler Gum Prophy Paste with Novamin

- Pathway: 510(k) (Traditional)
- Applicant: Usbiomaterials Corp.
- Decided: Jul 11, 2003 after 196 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: 1 generation back to K002989 (2000). 1 ancestor in all.
17 later devices descend from it; 5 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002989: Proclude, Ortek Therapeutics, Inc. (2000) Summary page 2.

## Most influential descendants
- K040858: Oralief Therapy for Sensitive Teeth (2004), 7 descendants of its own
- K041371: Butler Nucare Prophylaxis Paste with Novamin (2004), 3 descendants of its own
- K040473: Oravive Tooth Revitalizing Paste (2004), 3 descendants of its own
- K120176: Senzzzzz Away (2012), 2 descendants of its own
- K103461: Colgate Desensitizing Dental Cream (2011), 2 descendants of its own

## Indications for use
Butler GU@' Prophylaxis Paste withNovaMinQ is intended for cleaning and polhhing procedures as a part of a professionally administered dental prophylaxis treatment. Sacondadly, Butler GUM@Prophylaxis Paste with NovaMinQ can be used for the immediate relief of tooth sensitivity, post-scaling and root planing.

Source page: https://510kreport.com/device/K024343
Methodology: https://510kreport.com/methodology