# K042722: Aloclair Oral Spray

- Pathway: 510(k) (Traditional)
- Applicant: Sinclair Pharmaceuticals, Ltd.
- Decided: Jan 13, 2005 after 104 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: 3 generations back to K983182 (1998). 4 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K040950: Aloclair Oral Gel, Sinclair Pharmaceuticals, Ltd. (2004). Our reading of the summary gave K049050, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Sinclair Aloclair Oral Gel”.
- K023155: Aloclair Oral Rinse, Sinclair Pharmaceuticals, Ltd. (2002) Summary page 1.

## Most influential descendants
- 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
ALOCLAIRTM ORAL SPRAY is indicated for all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers caused by braces and ill fitting dentures and diffused aphthous ulcers.

Source page: https://510kreport.com/device/K042722
Methodology: https://510kreport.com/methodology