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510(k) Data Aggregation
K Number
K153230Device Name
ShefaBone SCPC Resorbable Bone Graft
Manufacturer
THE IMPLANTECH INC./SHEFABONE
Date Cleared
2016-07-14
(251 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
THE IMPLANTECH INC./SHEFABONE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ShefaBone SCPC Resorbable Bioactive Bone Graft, is a silica-calcium phosphate composite, synthetic bone graft material for use in oral, dental intraosseous, and maxillofacial bone defects. Typical uses include:
- Periodontal / infrabony defects
- Ridge augmentation (sinusotomy, osteotomy, cystectomy)
- Extraction sites (ridge maintenance/augmentation, implant preparation/ placement)
- Sinus lifts
- Cystic cavities
- Oral and maxillofacial augmentation
Device Description
ShefaBone SCPC Resorbable Bioactive Bone Graft, is a silica-calcium phosphate composite, synthetic bone graft material. It is resorbable and has a porous structure with a particle size of 90-710 micron. It is processed by thermal treatment to bond the chemical components together. It is packaged in a sealed glass vial containing 1 gm (1cc) of SCPC particles, sealed in an aluminum sterilization pouch, and sterilized by Gama radiation.
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