DALI Acellular Dermis

Acellular dermal matrix (ADM) or acellular dermis, has the natural elasticity of human skin. It is generally used for root coverage, gingival augmentation, or soft tissue augmentation around implants, when a CTG or FGG with autogenous tissue is not an option. DALI ® ADM, from DDSGadget, is provided by Surgenex, a leading provider of the highest quality tissue allografts.

• Compare to Alloderm ¹ and Puros Dermis¹
• No Refrigeration - Store At Room Temperature 
• Minimally processed to preserve the extracellular matrix
• Can be shaped with scissors or a scalpel
• Thickness approximately 1mm to 1.3 mm
• Resorption: 3 to 4 months

Acellular dermal matrix (ADM) or acellular dermis is a soft connective tissue graft generated by a decellularization process that preserves the intact extracellular skin matrix. Upon implantation, this structure serves as a scaffold for donor-side cells to facilitate subsequent incorporation and revascularization.
These human derived dermal grafts are decellularized to remove cellular components and preserve the biological properties that promote revascularization and repair. DALI ® ADM acellular dermis, has the natural elasticity of human skin. DALI ® ADM is minimally processed to remove epidermal and dermal cells while preserving the extracellular matrix of the dermis. The grafts are freeze-dried and sterilized providing at least 2 years of shelf life at room temperature. DALI® ADM is available in a variety of sizes and can be shaped with scissors or a scalpel.
An ADM is generally used for root coverage, gingival augmentation, or soft tissue augmentation around implants, when a CTG or FGG with autogenous tissue is not an option, i.e. a secondary surgical site is not an option for a variety of reasons.
Applications include:

• root coverage
• gingival augmentation
• soft tissue augmentation around implants
• soft tissue ridge augmentation

Precautions

• DALI® ADM has a distinct basement membrane and dermal surface. (See the IFU and Questions and Answers)
• Do not bend DALI® ADM before rehydration.
• Normal rehydration of DALI® ADM is usually accomplished in 20 minutes.  
• If any hair is visible, remove before implantation.
• DALI® ADM may be aseptically trimmed to required dimensions, if necessary.
• In case of 1X1 size of DALI® ADM, it does not have the Paper backing

Available in a variety of sizes and thickness, and can be shaped with scissors or a scalpel.
Resorption Time:

• 3 to 4 months (thin)

STERILIZATION
This tissue allograft has been sterilized, via Gamma irradiation, to a SAL of 10-6 (Sterility Assurance Level). This allograft must not be sterilized or re-sterilized by your facility.
DO NOT RE-STERILIZE.
Tissue Source: Surgenex
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).
1. Alloderm is a registered trademark of LifeCell. Puros is a registered trademark of Zimmer Biomet.