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510(k) Data Aggregation
K Number
K113645Device Name
REGENEROSS ALLOGRAFT PLUS MINERLIZED
Manufacturer
BIOMET INTERPORE CROSS
Date Cleared
2012-01-20
(39 days)
Product Code
NUN
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
BIOMET INTERPORE CROSS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RegenerOss Allograft Putty Plus Mineralized is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including: localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects.
Device Description
Bone Filling Material used for augmenting deficient bone or filling bone defects in oral/dental applications. Allograft (Bone) Putty containing human allograft bone tissue (DBM) and mineralized cancellous chips, from the same donor, combined with a lipid carrier.
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