# K130959: Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield; Aftamed Junior Gel

- Pathway: 510(k) (Traditional)
- Applicant: Bioplax Limited
- Decided: Apr 4, 2014 after 364 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: 5 generations back to K983182 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053342: Gengigel Mouthrinse, Ricerfarma Srl (2007) Summary page 8.

## Indications for use
Aftamed® Mouthwash provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery. Aftamed® 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: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery. Aftamed® 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: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery. Aftamed® Shield provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery. Aftamed® Junior 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: aphthous ulcers caused by disease; traumatic ulcers caused by braces, or oral surgery.

Source page: https://510kreport.com/device/K130959
Methodology: https://510kreport.com/methodology