# K152201: MedActive Oral Gel and Spray

- Pathway: 510(k) (Traditional)
- Applicant: Medactive Oral Pharmaceuticals, LLC
- Decided: Dec 30, 2015 after 146 days
- Product code: LFD (Saliva, Artificial)
- 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: 1 generation back to K123731 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123731: Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray, Glaxosmithkline Consumer Healthcare (Gskch) (2013) Summary page 4.

## Most influential descendants
- K171542: TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges (2018), 0 descendants of its own

## Indications for use
1. Provides symptom relief from Dry Mouth and low saliva including: Oral discomfort Mucosal soft tissue dryness Oral side effects of illness, therapies, and medications 2. Soothes moistens and lubricates 3. Hydrates soft tissue

Source page: https://510kreport.com/device/K152201
Methodology: https://510kreport.com/methodology