DALI Flex Graft, Cortical Bone Sheet

• Proprietary processing leaves a cortical sheet that is flexible, allowing it to be easily adapted for use in a 3 wall defect or an onlay to cover a graft site.
• Product retains enough rigidity to allow it to be easily tucked into a periosteal envelope (as compared to a membrane) and maintains its position during flap closure and suturing
• Rehydrates quickly and can be easily shaped with scissors or scalpel. Can be tacked or sutured.
• Provides 3 dimensional osteoconductive scaffold that promotes revascularization and in-growth of new bone.
• Demineralization process exposes BMP-2 content native to tissue. Each Lot is assayed and tested for it's osteoconductive potential post sterilization.

Common Applications include:

• Repair of 3 Wall defects
• Repair of access windows
• Ridge Augmentations

Tissue Source: Surgenex

DALI™ allografts are processed by Surgenex.

The grafts are freeze-dried and sterilized using low-dose gamma irradiation to achieve a sterility assurance level (SAL) of 10-6. The grafts should be stored in ambient temperatures (59-86º F or 15-30º C) and have a shelf-life of up to five (5) years from the date of packaging. CellRight’s proprietary next-generation BioRinseTM processing technology has been proven to preserve native bone morphogenic proteins (BMP’s).

Surgenex® is an industry leading biopharmaceutical company, providing regenerative medicine solutions that set the industry standard in quality and safety. Surgenex® uses its patented Excellion® process to produce minimally manipulated products that adhere to strict regulatory standards. Following these standards allows Surgenex® to sell approved allograft products with confidence to healthcare providers. This human tissue allograft is processed and packaged by Surgenex.

All tissue was recovered, processed, stored and distributed for use in accordance with the standards of the American Association of Tissue Banks (AATB), the FDA requirements for Human Cellular and Tissue Based Products (HCT/Ps 21 CFR Part 1271), and applicable State regulations. Surgenex® has determined the Donor to be eligible, based on the results of screening and testing. Screening includes a review of medical and social history, available hospital records, infectious disease testing, autopsy reports (if performed), and physical examination of the Donor, at the time of recovery. The Donor has been tested using FDA licensed, approved, or cleared donor screening test kits. Communicable disease testing has been performed by a laboratory registered with the FDA to perform donor testing in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS).