# K150914: Dash-Topic Plus Cream

- Pathway: 510(k) (Traditional)
- Applicant: Founders Science Group, LLC
- Decided: Apr 21, 2016 after 381 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: 7 generations back to K961758 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110727: Hylatopicplus Cream, Precision Dermatology Incorporated (2011) Summary page 4.

## Indications for use
Under the supervision of a healthcare professional, Dash-Topic Plus Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Dash-Topic Plus Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Source page: https://510kreport.com/device/K150914
Methodology: https://510kreport.com/methodology