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510(k) Data Aggregation
K Number
K080308Device Name
BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD
Manufacturer
BIOSCAFFOLD INTERNATIONAL PTE LTD
Date Cleared
2008-04-14
(69 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
BIOSCAFFOLD INTERNATIONAL PTE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bio-Scaffold Bioscaff Alvelac Scaffold is a bioabsorbable implantable matrix intended for use as a space-making barrier in the treatment of periodontal defects and maxillofacial guided tissue regeneration procedures, including preservation and conservation of alveolar bone height and volume, ridge and extraction site augmentation, sinus lifts, and treatment of associated cystic defects. It is also intended for use as a grafting material containment matrix.
Device Description
The Bioscaff™ Alvelac™ is a synthetic polymer scaffold synthesized from Poly (lactic-coglycolic) acid (PLGA) and poly vinyl acetate (PVA). The scaffold is designed with macro channels and micropores for cell adhesion, as well as to provide the necessary space for bone and tissues to grow.
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