# K202000: Silatrix Oral Gel

- Pathway: 510(k) (Traditional)
- Applicant: Sa3, LLC
- Decided: Nov 20, 2020 after 123 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: 5 generations back to K953423 (1995). 6 ancestors in all.
1 later device descends 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)
- K123904: Prothelial, Mueller Medical International, LLC (2013) Summary page 4.

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

## Recalls of this device
- Feb 21, 2022 · Class II · Z-0856-2022: Due to failure of microbial testing for total aerobic microbial count (TAMC).

## Indications for use
Silatrix Oral Gel 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 oral gel may be used in the management of mouth lesions 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/K202000
Methodology: https://510kreport.com/methodology