# K040950: Aloclair Oral Gel

- Pathway: 510(k) (Traditional)
- Applicant: Sinclair Pharmaceuticals, Ltd.
- Decided: Jun 21, 2004 after 70 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: 2 generations back to K983182 (1998). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023155: Aloclair Oral Rinse, Sinclair Pharmaceuticals, Ltd. (2002) Summary page 1.
- K013056: Gelclair Concentrated Oral Gel, Sinclair Pharmaceuticals, Ltd. (2001) Summary page 1.

## Most influential descendants
- 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

## Indications for use
SINCLAIR ALOCLAIRTM ORAL GEL is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further irritation.

Source page: https://510kreport.com/device/K040950
Methodology: https://510kreport.com/methodology