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510(k) Data Aggregation
K Number
K053260Device Name
OSSIX -PLUS
Manufacturer
COLBAR LIFESCIENCE LTD.
Date Cleared
2006-02-22
(92 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
COLBAR LIFESCIENCE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ossix™-PLUS biodegradable collagen membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:
- Ridge augmentation for later implant insertions. .
- . Simultaneous ridge augmentation and implant insertions.
- Ridge augmentation around implants inserted in delayed extraction sites. .
- . Ridge augmentation around implants inserted in immediate extraction sites.
- Alveolar ridge preservation consequent to tooth (teeth) extraction(s). .
- . Over the window in lateral window sinus elevation procedures.
- In implants with vertical bone loss due to infection, only in cases where . satisfactory debridment and implant surface disinfection can be achieved.
- . In intra bony defects around teeth
- For treatment of recession defects, together with coronally positioned flap
- In furcation defects in multi rooted teeth
Device Description
Ossix-Plus is a resorbable dental membrane made from ribose cross-linked porcine collagen. The membrane provides a barrier that guides bone regeneration, segregates tissue layers, or supports periodontal tissue regeneration. Barrier membranes are placed over bony or periodontal defects to prevent the population by cells from the gingival connective tissue and epithelium. This segregation of tissues by the membrane creates a cavity into which bone forming cells migrate and leads to new bone formation, as well as allowing cementum with inserting periodontal fibers to reform on exposed roots. The regeneration of lost periodontal structures (bone, periodontal ligament, and connective tissue attachment) around teeth is known as guided tissue regeneration ("GTR").
Because Ossix-Plus is a collagen membrane of animal origin, the device resorbs over time (within approximately 8 months based on animal model data). A second surgical procedure to remove the membrane is not required.
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