Device Dossier

RESORBA Fleece - Collagen haemostatic agent

Device Dossier for RESORBA Fleece - Collagen haemostatic agent (Collagen haemostatic agent, Class III, sponsor Ozdent). ARTG record, intended purpose,…

Intended purpose

RESORBA Fleece is used as a haemostatic agent after tooth extraction and oral surgery. RESORBA Fleece can be combined with fibrin glue in patients with increased risk of bleeding.

Functional description

1 RESORBA Fleece 1.8cmx3.6cm contains 18.1mg, and 3cmx7cm contains 58.8mg of native collagen fibrils of equine origin. The application of RESORBA Fleece into the defect cavity supports the stabilization of the produced blood clot whilst helping to control bleeding at the application site. Should be used in dry state with light pressure, inserted into the extraction socket or the cavity as required. Can be sutured over and/or held in place with fibrin glue as required. Absorbed within 6-8 weeks.

TGA Public Summary