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510(k) Data Aggregation
K Number
K200623Device Name
OssGuide
Manufacturer
Date Cleared
2020-10-02
(207 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Sk bioland Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OssGuide is recommended for:
- Simultaneous use of GBR-membrane (OssGuide) and implants;
- Augmentation around implants placed in immediate extraction sockets;
- Augmentation around implants placed in delayed extraction sockets;
- Localized ridge augmentation for later implantation;
- Alveolar ridge reconstruction for prosthetic treatment;
- Aid regeneration of bone defects after root resection, cystectomy, removal of retained teeth;
- Guided bone regeneration in dehiscence defects
Device Description
OssGuide (Absorbable collagen membrane) is made of purified collagen without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. The OssGuide is a collagen membrane obtained by a standardized controlled manufacturing process. The OssGuide has a porous and fibrous microstructure that prevents the ingrowth of fibrous tissue into the bone defect. OssGuide functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. OssGuide is substantially resorbed within 24 weeks after implantation.
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