# K053342: Gengigel Mouthrinse

- Pathway: 510(k) (Traditional)
- Applicant: Ricerfarma Srl
- Decided: Mar 13, 2007 after 467 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: 4 generations back to K983182 (1998). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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.
- K040950: Aloclair Oral Gel, Sinclair Pharmaceuticals, Ltd. (2004) Summary page 3.
- K042722: Aloclair Oral Spray, Sinclair Pharmaceuticals, Ltd. (2005) Summary page 4.
- K023155: Aloclair Oral Rinse, Sinclair Pharmaceuticals, Ltd. (2002) Summary page 6.

## Most influential descendants
- K130959: Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield; Aftamed Junior Gel (2014), 0 descendants of its own

## Indications for use
Gengigel® Junior provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers. Gengigel® Prof Fluid adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Fluid relieves pain by providing a barrier to protect the area from ongoing insult and discomfort. Gengigel Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers. Gengigel® Prof Gel adheres to the oral mucosa and forms a protective film over the lesions and irritation due, to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Gel relieves pain by providing a barrier to protect the area from ongoing insult and discomfort. Gengigel Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers. Gengigel Mouthrinse provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Source page: https://510kreport.com/device/K053342
Methodology: https://510kreport.com/methodology