# K042400: Mucotrol Concentrated Oral Gel Wafer

- Pathway: 510(k) (Traditional)
- Applicant: Belcher Pharmaceuticals, Inc.
- Decided: Nov 24, 2004 after 82 days
- Product code: OLR (Oral Wound Dressing)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964852 (1997). 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)
- K013056: Gelclair Concentrated Oral Gel, Sinclair Pharmaceuticals, Ltd. (2001) Summary page 1.
- K964852: Radiacare Oral Wound Rinse, Carrington Laboratories, Inc. (1997) Summary page 1.

## Recalls of this device
- Sep 25, 2006 · Not classified · Z-0398-2007: Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.

## Indications for use
MUCOTROL T M CONCENTRATED ORAL GEL WAFER 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 8Y CHEMOTHERAPY OR RADIOTHERAPY), IRRITATION DUE TO ORAL SURGERY AND TRAUMATIC ULCERS CAUSED BY BRACES OR ILL FITTING DENTURES OR DISEASES. ALSO INDICATED FOR DIFFUSE APTHOUS ULCERS.

Source page: https://510kreport.com/device/K042400
Methodology: https://510kreport.com/methodology