# K071483: Tetrix Cream

- Pathway: 510(k) (Traditional)
- Applicant: Coria Laboratories, Ltd.
- Decided: Apr 4, 2008 after 310 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: 3 generations back to K961758 (1996). 4 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K024367: Sinclair Wound and Skin Emulsion, Sinclair Pharmaceuticals, Ltd. (2003) Summary page 1.
- K041342: Impruv a.I. Cream Wound and Skin Emulsion, Stiefel Laboratories, Inc. (2005) Summary page 1.

## Most influential descendants
- K113807: Dexeryl Cream (2012), 0 descendants of its own
- K093159: PR Cream (2010), 0 descendants of its own

## Indications for use
TetrixTM Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. Tetrix TM Cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Source page: https://510kreport.com/device/K071483
Methodology: https://510kreport.com/methodology