# K121698: Nupro Sensodyne Prophylaxis Paste with Novamin

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Aug 6, 2012 after 59 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures, including prior to and after scaling and root planing as part of a professionally administered dental prophylaxis treatment. Secondarily, NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity and for lasting sensitivity relief for up to 4 weeks (28 days) after just one application.

Source page: https://510kreport.com/device/K121698
Methodology: https://510kreport.com/methodology