OsseoSeal
OsseoSeal Resorbable Porcine Collagen Membrane
SKU: OSSGUIDE-TG-1
OsseoSeal provides superior barrier function, while maintaining ideal handling characteristics and membrane adaptibility. Substantially Equivalent to BIO-GIDE®.
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- Substantially Equivalent to BIO-GIDE (see data below)
- Material: Type 1 porcine pericardium.
- Resorption time: 3 months.
- Fast hydration and excellent tensile strength.
- Amazing adaptation to various defects.
- Excellent tear function and duration.
Guides and Resources
Questions About OsseoSeal Resorbable Porcine Collagen Membrane
Is this substantially equivalent to Bio Gide?
Yes. The FDA concluded in the 510K submission for Ossguide(K200623) (link provided in detail description below) that it is substantially equivalent to Bio-Guide, the predicate device used in the 510K submission. If you read the submission, it is noted that in many respects Ossguide is identical to Bio-Guide. The primary difference is that Bio-Guide is made from Porcine peritoneum, while Ossguide is manufactured from Porcine pericardium.
Additional Information for OsseoSeal Resorbable Porcine Collagen Membrane
OsseoSeal (private label brand of Ossguide) is a resorbable collagen membrane derived from purified porcine pericardium. This membrane was designed to provide superior barrier function, while maintaining ideal handling characteristics. Once hydrated, the OsseoSeal collagen membrane has excellent tensile strength and is not easily torn. This ensures that clinicians can easily stretch the membrane without tearing. OsseoSeal is an ideal membrane for GBR procedures.
OsseoSeal is recommended for:
- Simultaneous use of GBR-membrane (OssGuide) and implants;
- Augmentation around implants placed in immediate extraction sockets;
- Augmentation around implants placed in delayed extraction sockets;
- Localized ridge augmentation for later implantation;
- Alveolar ridge reconstruction for prosthetic treatment;
- Aid regeneration of bone defects after root resection, cystectomy, removal of retained teeth;
- Guided bone regeneration in dehiscence defects
In a controlled study, OssGuide maintained its contour until 8 weeks, lost most of its integrity after 12 weeks, and disappeared by biodegradation at 24 weeks.
Substantially Equivalence to BIO-GIDE® The FDA concluded in the 510K submission for Ossguide (K200623) that it is substantially equivalent to Bio-Guide, the predicate device used in the 510K submission.
Placement
Please use our Guides below to learn about proper OsseoSeal placmenet. OssGuide can be trimmed to the size and shape of the defect. A piece of sterile Tyvek may be used as a template for membrane sizing and trimming. OssGuide should overlap the walls of the defect by at least 2 mm to allow complete bone contact and to prevent gingival connective tissue invasion below the material. The membrane may be secured in place with sutures, tacks, or by means of sufficient contact with the mucoperiosteal flap to avoid displacement and micro motion during healing. To facilitate proper healing, ensure that there is tension-free primary closure of the soft tissue flap covering the membrane.
Comparison of Tensile Strength with "other product"

Osteoblast Cell Adhesion Test
After the cultivation by U-2OS osteoblast cell line it is confirmed osteoblast cell line, it is confirmed by SEM that bone cell is well adhered and replicated on adhered and replicated on surface of OssGuideTM in day 3.

Bone Volume, Bone Intensity Test (Rat’s Calvarial Bone Defect Model) In reviewing the result of micro CT in rat’s calvarial bone defect models, after 12 weeks from the operation, a bone volume of OssGuideTM is increased up to 93.15 and bone intensity is up to 1.68. In reviewing the opinion of tissue inspection, after 12 weeks from the operation, OssGuide shows perfect bone generation


Clinical Application of OsseoSeal

1. BioGide® is a registered trademark of Geistlich