# K023155: Aloclair Oral Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Sinclair Pharmaceuticals, Ltd.
- Decided: Nov 25, 2002 after 63 days
- Product code: OLR (Oral Wound Dressing)
- Device class: U
- 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 K983182 (1998). 2 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013056: Gelclair Concentrated Oral Gel, Sinclair Pharmaceuticals, Ltd. (2001)
- K983182: Aloe Therapy Oral Rinse, Carrington Laboratories, Inc. (1998) Summary page 1.

## Most influential descendants
- K040950: Aloclair Oral Gel (2004), 3 descendants of its own
- K042722: Aloclair Oral Spray (2005), 2 descendants of its own
- K053342: Gengigel Mouthrinse (2007), 1 descendant of its own
- K130959: Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield; Aftamed Junior Gel (2014), 0 descendants of its own
- K082553: Rexastom Oral Ease (2008), 0 descendants of its own

## Indications for use
SINCLAIR ALOCLAIR™ ORAL with Aloe Vera extract, adheres to the mucosal surface and provides rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions, including ulcers caused by braces and ill fitting dentures.

Source page: https://510kreport.com/device/K023155
Methodology: https://510kreport.com/methodology