# K203091: MucoLock Oral Gel

- Pathway: 510(k) (Traditional)
- Applicant: Pcca, Inc.
- Decided: Feb 12, 2021 after 122 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 K013056 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081372: Gelx Oral Gel, Bmg Pharma, LLC (2009) Summary page 4.

## Indications for use
MucoLock has a mechanical action which provides 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 or Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, traumatic ulcers caused by braces and ill-fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.

Source page: https://510kreport.com/device/K203091
Methodology: https://510kreport.com/methodology