# K983182: Aloe Therapy Oral Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Carrington Laboratories, Inc.
- Decided: Dec 10, 1998 after 90 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
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063148: Sock IT! Oral Pain Gel (2007), 8 descendants of its own
- K023155: Aloclair Oral Rinse (2002), 5 descendants of its own
- K210211: PuraStat-OM (2021), 4 descendants of its own
- K213552: PuraStat-RM (2022), 3 descendants of its own
- K040950: Aloclair Oral Gel (2004), 3 descendants of its own

## Indications for use
The Carrington Laboatories Caraloe Oral Rinse provides fast pain relief and is recommended for the management of all types of oral wounds, mouth sore injuries and ulcers of the oral mucosa, including canker sores and traumatic ulcers such as those caused by braces and ill-fitting dentures. Safe if swallowed

Source page: https://510kreport.com/device/K983182
Methodology: https://510kreport.com/methodology