# K062502: Osspray Cleaning Compound

- Pathway: 510(k) (Traditional)
- Applicant: Ospray, Ltd.
- Decided: Dec 15, 2006 after 112 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: 3 generations back to K002989 (2000). 3 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K041371: Butler Nucare Prophylaxis Paste with Novamin, Novamin Technology, Inc. (2004) Summary page 1.
- (no number) Prophy Powder: named in the summary without a submission number

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

## Indications for use
The OSspray Cleaning Compound is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. The OSspray Cleaning Compound is also intended to provide relief from tooth sensitivity during the prophylaxis treatment.

Source page: https://510kreport.com/device/K062502
Methodology: https://510kreport.com/methodology