Welcome to the Future of Oral Health
At BioCellgraft, we are proud to introduce OraFyl-M™, a next-generation guided bone regeneration (GBR) membrane that leverages the latest in regenerative oral medicine. Powered by the same pioneering science behind OraFyl™, OraFyl-M™ is designed to support clinicians and patients in achieving superior outcomes in soft tissue and bone regeneration.
The Science of Regenerative Oral Medicine
Regenerative dentistry is transforming traditional approaches to oral health. At the core of this field is the principle of cell and tissue enhancement, combining extracellular matrix (ECM) components with precision surgical techniques to restore soft tissue, bone, and periodontal structures. These biologically driven methods enable the regeneration of damaged or compromised tissues—bringing renewed potential to patients with complex dental conditions.
Why OraFyl-M™ is Unique
OraFyl-M™™ is a decellularized, dehydrated human amniotic membrane (DDHAM) derived from the placenta of healthy, full-term pregnancies. The amnion—the innermost layer of the placenta—is carefully separated from the chorion, thoroughly washed, and preserved without altering its native matrix structure, elasticity, or strength. This meticulous process ensures:
No antigenicity – immunologically inert
Maintained natural ECM architecture
Complete sterility, while preserving bioactive potential
OraFyl-M™ is manufactured in accordance with rigorous safety standards set by the American Association of Blood Banks (AABB) and the U.S. Food and Drug Administration (FDA). It has passed testing for:
Cytotoxicity
Hemolysis
Irritation
Endotoxins
Pyrogenicity
Key Features and Clinical Advantages
No preparation required – ready to use with no thawing, rinsing, or soaking
Flexible and conformable – easily adapts to defect geometry, including around implants or bone grafts
Bidirectional orientation – can be applied with either side facing the wound
Suture-free adherence – may be secured with standard surgical methods if needed
Translucent grid pattern – visible until hydration, allowing clinicians to visualize underlying tissue
Convenient storage – ambient room temperature; 10-year shelf
Intended Use
OraFyl-M™ is indicated for oral soft tissue management and bone regeneration procedures, including:
Alveolar ridge preservation
GBR and GTR procedures
Peri-implant soft tissue augmentation
Socket management and wound covering
Its unique handling properties and biological profile make it a preferred choice for clinicians seeking predictable and regenerative outcomes.
OraFyl-M™ isn’t just a membrane—it’s a biologically active scaffold for healing. Welcome to a new era in oral regenerative care.
OraFyl-M™ is a decellularized, dehydrated human amniotic membrane (DDHAM) used in dentistry to help regenerate gum and soft tissue. It’s made from the amnion, the inner lining of the placenta, collected after healthy, full-term births and processed to remove all cells, leaving behind a pure, biologically active scaffold.
OraFyl-M™ works by leveraging the natural biological properties of the human amniotic membrane, which plays a critical role in fetal protection and development. When applied in oral surgery, OraFyl-M™ acts as a biological scaffold—a protective and regenerative interface between tissues—that supports and enhances the body’s own healing mechanisms.
OraFyl-M™ promotes faster healing with reduced inflammation and discomfort. It supports the body’s natural ability to regenerate soft tissue, especially in the oral cavity. Its unique biological structure enhances clinical outcomes in gum and implant-related procedures. OraFyl-M™ also helps maintain soft tissue volume and improves the aesthetic and functional recovery of treated areas.
OraFyl-M™ is used for treating soft tissue defects in the mouth, especially those caused by surgery, gum recession, or implant procedures. It is particularly effective in:
Enhancing keratinized tissue around implants
Supporting gingival regeneration
Protecting surgical sites (e.g., after extractions or grafting)
Improving outcomes in esthetic zones (e.g., papilla augmentation)
Yes, OraFyl-M™ is manufactured under strict quality control and regulatory standards. It is derived from allogeneic decellularized human placental connective tissue, processed to ensure safety and efficacy for clinical use.
OraFyl-M™ has undergone evaluation to meet regulatory standards of the Food and Drug Administration (USA) and other Health Authorities. For the most current approval status and regulatory details, please refer to our official website or contact us directly.
OraFyl-M™ is available for purchase by licensed healthcare providers. For ordering information, please contact BioCellgraft’s sales team through our website or via email at info@biocellgraft.com.
For more detailed information about OraFyl-M™, including clinical guidelines and support, please visit our website at www.biocellgraft.com or reach out to our customer support team.