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510(k) Data Aggregation
K Number
K240133Device Name
Xenograft Bovine Bone Particulate
Manufacturer
Collagen Solutions, LLC
Date Cleared
2024-08-16
(211 days)
Product Code
NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Collagen Solutions, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Xenograft Bovine Bone Particulate is intended for use in dental surgery.
The products may be used in surgical procedures such as:
* Augmentation or reconstructive treatment of alveolar ridge
* Filling of periodontal defects
* Filling of defects after root resection, apicocectomy, and cystectomy
* Filling of extraction sockets to enhance preservation of the alveolar ridge
* Elevation of maxillary sinus floor
* Filling of defects in conjunction with products intended for Guided Bone Regeneration (GBR)
* Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
Device Description
The Xenograft Bovine Bone Particulate is a porous bone mineral matrix that is used in periodontal, oral, and maxillofacial surgery. It has a trabecular architecture, interconnecting macro and micro pores and consistency which allows formation and ingrowth of new bone. The particulate is available in clinically relevant sizes. The anorganic bone composition meets all requirements found in ASTM 1581-08: Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is packaged, and electron beam irradiated to meet all requirements and is non-pyrogenic. Using standard dental techniques, the dentist will loosely pack the xenograft particulate granules into the osseous defect using sterile instruments.
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