# K033729: Collagen Dental Wound Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Mar 17, 2004 after 110 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960724 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011695: Collagen Dental Membrane, Collagen Matrix, Inc. (2001)
- K003339: Collagen Periodontal Membrane, Collagen Matrix, Inc. (2001) Summary page 1.

## Indications for use
Collagen Dental Sponge Membranes are intended for use in patients with moderate to severe periodontal disease as a resorbable material for placement in periodontal defects to aid in wound healing post periodontal surgery.

Source page: https://510kreport.com/device/K033729
Methodology: https://510kreport.com/methodology