# K110388: Collacare Dental

- Pathway: 510(k) (Traditional)
- Applicant: Innocoll Pharmaceuticals, Ltd.
- Decided: Aug 9, 2011 after 180 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: 7 generations back to K910944 (1991). 12 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092805: Collagen Sponge, Innocoll Pharmaceuticals (2010) Summary page 1.
- K040403: Collagen Wound Dressing - Oral, Collagen Matrix, Inc. (2004) Summary page 1.

## Most influential descendants
- K122115: Collagen Dental Wound Dressings (2012), 5 descendants of its own
- K152600: Collagen Dental Wound Dressings (2016), 2 descendants of its own
- K133290: Collacare Dental (2014), 1 descendant of its own
- K253758: Dental Cone; Dental Sponge (2025), 0 descendants of its own
- K243071: Bovine Dermis Collagen Dermal Matrix (2024), 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/K110388
Methodology: https://510kreport.com/methodology