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510(k) Data Aggregation
K Number
K111087Device Name
FOUNDATION
Manufacturer
OLYMPUS TERUMO BIOMATERIALS CORPORATION
Date Cleared
2011-11-29
(224 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
OLYMPUS TERUMO BIOMATERIALS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FOUNDATION device is a collagen-based bone filling augmentation material for use in filling of extraction sockets.
Device Description
The FOUNDATION bone filler device is a sponge-like absorbable natural collagen plug designed to be used as indicated. FOUNDATION consists of approximately 85-95% Type I collagen and approximately 5-15% Type III collagen from bovine dermis.
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K Number
K081561Device Name
OSFERION D
Manufacturer
OLYMPUS TERUMO BIOMATERIALS CORPORATION
Date Cleared
2008-07-28
(55 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
OLYMPUS TERUMO BIOMATERIALS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
- 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
OSferion D is a white porous material composed of Beta-tricalcium phosphate(ß-TCP). It is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. The ceramic material complied with US standard specification ASTM F 1088-04. The OSferion D product range consists of two product types with porosities of 75% and of three granule sizes (G0:0.15~0.8mm,G1:0.5~1.5mm,G2:1.0~3.0mm).
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K Number
K080065Device Name
OSFERION
Manufacturer
OLYMPUS TERUMO BIOMATERIALS CORPORATION
Date Cleared
2008-05-02
(113 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
OLYMPUS TERUMO BIOMATERIALS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Device Description
OSferion is a white porous material composed of ß-tricalcium phosphate(ß-TCP). It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSfenon is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The OSferion product range consists of two product types with porosities of 75% and 60%. Products are supplied in blocks, cylinders, granules and wedges.
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