# K013056: Gelclair Concentrated Oral Gel

- Pathway: 510(k) (Traditional)
- Applicant: Sinclair Pharmaceuticals, Ltd.
- Decided: Dec 21, 2001 after 101 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.
21 later devices descend from it; 9 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Carrington Laboratories Radiacare™ Oral Wound Rinse: named in the summary without a submission number

## Most influential descendants
- K062795: Mugard Mucoadhesive Oral Wound Rinse (2006), 5 descendants of its own
- K023155: Aloclair Oral Rinse (2002), 5 descendants of its own
- K140558: Proctigard (2014), 4 descendants of its own
- K043587: Sucralfate and Carafate Paste Kits (2006), 4 descendants of its own
- K213552: PuraStat-RM (2022), 3 descendants of its own

## Indications for use
Sinclair Gelclair® CONCENTRATED ORAL GEL, has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy), iritation due to oral surgery and traumatic ulcers caused by braces or ill fitting dentures or disease. Also indicated also for diffuse aphthous ulcers.

Source page: https://510kreport.com/device/K013056
Methodology: https://510kreport.com/methodology