# K103114: Osspray Sylc CR

- Pathway: 510(k) (Traditional)
- Applicant: Osspray, Ltd.
- Decided: Mar 14, 2011 after 144 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: 4 generations back to K002989 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062502: Osspray Cleaning Compound, Ospray, Ltd. (2006) Summary page 1.

## Indications for use
OSspray Sylc. CR compound is a single-phase calcium phosphosilicate ceramic product intended for the removal of weakened or decayed small enamel lesions, in addition to the cleaning of enamel surfaces and providing relief of hypersensitivity associated with exposed dentin and open dentinal tubules.

Source page: https://510kreport.com/device/K103114
Methodology: https://510kreport.com/methodology