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510(k) Data Aggregation
K Number
K140021Device Name
TI-OSS
Manufacturer
Date Cleared
2015-06-05
(518 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
CHIYEWON
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Ti-oss® is intended for use in dental surgery.
The product is recommended for the following surgeries :
* Augmentation or reconstructive treatment of alveolar ridge
* Filling of periodontal defects
* Filling of defects after root resection, apicoectorny, and cystectorny
* Filling of extraction sockets to enhance preservation of the alveolar ridge
* Elevation of 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
Device Description
Ti-oss is a sterile, porous bone mineral matrix produced by the removal of organic compounds from bovine bone. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by yirradiation.
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