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510(k) Data Aggregation
K Number
K103820Device Name
REPROBONE DENTAL GRAFTING MATERIAL
Manufacturer
Date Cleared
2011-11-03
(308 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
CERAMISYS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ReproBone is recommended for augmentation or reconstructive treatment of the alveolar ridge. Filling of infrabony periodontal defects. Filling of defects after root resection apicoectomy and cystectomy. Filling of extraction sockets to enhance preservation of the alveolar ridge. Elevation of the maxillary sinus floor. Filling of periodontal defects in conjunction with products intended for guided tissue regeneration (GTR) and guided bone regeneration (GBR). Filling of peri-implant defects in conjunction with products intended for guided bone regeneration (GBR).
Device Description
ReproBone® is a sterile, single-use, resorbable bone void filler. ReproBone® is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate. ReproBone" has a highly interconnected, highly porous structure, similar to that of human cancellous bone, and is available in the form of granules of size range 0.5 - 1.0mm, and also 0.8-1.5mm. Following placement in the bony voids or gap, ReproBone® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. ReproBone® gradually resorbs and is replaced with bone during the healing process
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K Number
K110554Device Name
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
Manufacturer
Date Cleared
2011-11-02
(247 days)
Product Code
Regulation Number
886.3320Why did this record match?
Applicant Name (Manufacturer) :
CERAMISYS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Ceramisys synthetic orbital implants of either hydroxyapatite or alumina oxide (alumina) are indicated for orbital implantation at the time of enucleation or evisceration of the natural eyeball. They may also be indicated for secondary implantation where extrusion, migration or other malfunction of the primary orbital implant has occurred.
Device Description
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