Related Products
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 Studies and Results
New bone formation plot for Synergy and Bio-Oss at different end-points
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
Additional Case Study