# K053166: Sinclair Oral Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Sinclair Pharmaceuticals Limited
- Decided: May 17, 2006 after 184 days
- Product code: NTO (Rinse, Oral, Antibacterial (By Physical Means))
- Device class: 2
- Regulation: 21 CFR 872.5580
- 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 DEN050001 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN050001: Decapinol Oral Rinse, Sinclair Pharmaceuticals Limited (2005). Our reading of the summary gave K041482, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN050001, Decapinol Oral Rinse (Sinclair Pharmaceuticals Limited), granted Apr 18, 2005; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Indications for use
SINCLAIR ORAL RINSE helps to prevent and reduce gingivitis, when used as directed. SINCLAIR ORAL RINSE serves as an adjunct to normal mechanical oral hygiene where this has proved inadequate.

Source page: https://510kreport.com/device/K053166
Methodology: https://510kreport.com/methodology