# K133290: Collacare Dental

- Pathway: 510(k) (Traditional)
- Applicant: Innocoll Pharmaceuticals
- Decided: May 1, 2014 after 188 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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: 9 generations back to K910944 (1991). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110388: Collacare Dental, Innocoll Pharmaceuticals, Ltd. (2011) Summary page 1.
- K122115: Collagen Dental Wound Dressings, Collagen Matrix, Inc. (2012) Summary page 1.

## Most influential descendants
- K253758: Dental Cone; Dental Sponge (2025), 0 descendants of its own

## Indications for use
Collacare Dental is indicated for the management of oral wounds and sores, including: *denture sores *oral ulcers (non-infected or viral) periodontal surgical wounds *suture sites *burns *surgical wounds and traumatic wounds

Source page: https://510kreport.com/device/K133290
Methodology: https://510kreport.com/methodology