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510(k) Data Aggregation
K Number
K142040Device Name
OCS-B COLLAGEN
Manufacturer
NIBEC CO LTD
Date Cleared
2015-07-31
(368 days)
Product Code
NPM, CLA
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
NIBEC CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OCS-B Collagen® 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 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
OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B") and 10% collagen in a block form in a blister and cylinderic form in a syringe and blister. It is sterilized by yirradiation.
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K Number
K133507Device Name
GUIDOSS
Manufacturer
NIBEC CO LTD
Date Cleared
2014-11-05
(356 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
NIBEC CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GuidOss® is recommended for:
- Simultaneous use of membrane (GuidOss®) and implants : 1.
- Augmentation around implants placed in immediate extract sockets; 2.
- 3. Augmentation around implants placed in delayed extraction sockets;
- 4. Localized ridge augmentation for later implantation;
- 5. Alveolar ridge reconstruction for prosthetic treatment
- 6. Filling of bone defects after root resection, cystectomy, removal of retained teeth.
- 7. Guided bone regeneration in dehiscence defects; and
- 8. Guided tissue regeneration procedures in periodontal defects.
Device Description
GuidOss® is made from pure type I collagen membrane obtained by a standardized controlled manufacturing process. The type I collagen is obtained from veterinary certified porcine and is carefully purified to avoid immunological reactions. GuidOss® membrane is manufactured by fibrillogenesis and crosslinking. The collagen fibers are self-assembled by the process of fibrillogenesis. The crosslinked collagen fibers exhibited increased mechanical strength, thermal stability and increased resistance to pepsin digestion compared to non-crosslinked collagen.
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