# K123904: Prothelial

- Pathway: 510(k) (Traditional)
- Applicant: Mueller Medical International, LLC
- Decided: Aug 7, 2013 after 231 days
- Product code: FRO (Dressing, Wound, Drug)
- 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: 4 generations back to K953423 (1995). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043587: Sucralfate and Carafate Paste Kits, Patrick D. Mcgrath Ph.D (2006) Summary page 1.
- K082856: Carapaste Oral Wound Dressing, Mcgrath Pharmaceuticals, Inc. (2008) Summary page 1.

## Most influential descendants
- K202000: Silatrix Oral Gel (2020), 1 descendant of its own
- K252425: Silatrix Oral Gel (2025), 0 descendants of its own

## Indications for use
ProTheliarIM & Orafate Sucralfate Malate Paste forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The paste may be used in the management of mouth lesions of all types including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery.

Source page: https://510kreport.com/device/K123904
Methodology: https://510kreport.com/methodology