Odontit SA
OsseoSeal Bovine Bone Graft
SKU: OSS-1000-05
Compares to BioOss. OsseoSeal bone, is made of deproteinized bovine bone and is indicated in bone regeneration.
0.25-1mm Particle Size.
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$50.00
$35.00
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- 510-K Approval by FDA as substantially equivalent to BioOss ®
- Sterilized with gamma-radiation at 25kGy. No potential immunological or infectious risks.
- Easy handling of material allows for precise graft placement. Adapts to the cavity shape.
- The high volume of interconnected pores promotes new bone formation and growth.
- Porosity of material allows for thorough revascularization.
- Particle structure helps to maintain space.
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Questions About OsseoSeal Bovine Bone Graft
Is this equivalent to BioOss
Yes. This product has 510-K Approval by FDA as substantially equivalent to BioOss.
Is this like CevOss?
Yes. Actually, this is the exact same product as CevOss. Both products are just private-label versions of SYNERGY bovine graft.
Additional Information for OsseoSeal Bovine Bone Graft
OsseoSeal bone, is made of deproteinized bovine bone and is indicated in bone regeneration. It provides a supportive structure for osteoconduction. The anorganic bone matrix of OsseoSeal bone has macro and microcopic structures that mimics human bone. The formation and ingrowth of new bone at implantation site of with OsseoSeal is enhanced due to its trabecular architecture and interconnecting macro and micro pores.
Note: SYNERGY is the manufacturer's (ODONTIT SA) name for this xenograft. SYNERGY is sold under the brand names of OsseoSeal and CevOss in the United States.
Based upon comparison of the intended use, biocompatibility, sterility, physical and chemical testing, and the performance evaluation of the subject and predicate device in an anatomically relevant animal model, and the results of clinical cases, Odontit concluded that SYNERGY (also sold under the brand name OsseoSeal and Cevoss) is substantially equivalent to the predicate devices Bio-Oss® and Equimatrix™.
The FDA granted approval of the Odontit 510-K demonstrating substantial equivalence in 2014. The 510-K approval letter is available here.
Clinical Results
New bone formation plot for Synergy and Bio-Oss at different end-points
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Remaining of the particle of the bone grafts (Synergy and Bio-Oss) at different end-points. For both Synergy and Bio-Oss, a trend was observed to increase bone volume as a function of time.
S: Arrows indicate Synergy bovine bone graft particles. Newly formed bone micro trabeculae (MT). (10x, H-E) B: Arrows indicate Bio-Oss bovine bone graft particles. Newly formed bone micro trabeculae (MT). (10x, H-E)
S: Arrows indicate Synergy particles. NB: new bone formation foci, OB: osteoblasts. (10x, H-E). B: Arrows indicate Bio-Oss particles. (10x, H-E).
S: Arrows indicate Synergy. Newly formed bone trabeculae (NB). (10x, H-E) B: Arrows indicate Bio-Oss. Presence of reparative fibrous tissue (RF) . Newly formed bone trabeculae (NB). (10x, H-E)
Pre surgical CAT. Circles indicates implantation area.
Post surgical CAT showing sinus elevation (left side) and implants placement. Arrows indicates the presence of Synergy