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510(k) Data Aggregation
K Number
K101827Device Name
OSTEOSCAF
Manufacturer
TEXAS INNOVATIVE MEDICAL DEVICES (DBA) SKELETAL
Date Cleared
2011-04-20
(293 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
TEXAS INNOVATIVE MEDICAL DEVICES (DBA) SKELETAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OsteoScaf™ bone grafting material is indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.
Device Description
OsteoScaf™ is a synthetic osteoconductive and bioresorbable bone grafting material composed of 3-phase biodegradable polymer and calcium phosphate composite, intended to fill and/or augment intraoral/maxillofacial osseous defects. It functions in the same manner as the predicate devices. The product is available as a particulate, cylinder, or block and is provided in sterile packaging in various dosage volumes.
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