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510(k) Data Aggregation
K Number
K051047Device Name
COLLOSS E BONE VOID FILLER
Manufacturer
OSSACUR AG
Date Cleared
2006-03-08
(317 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
OSSACUR AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
COLLOSS E is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. COLLOSS E is resorbed and replaced with bone during the healing process.
Device Description
COLLOSS E is a bone void filler extracted from the extracellular n diaphyseal equine bone. It is a lyophilizate in collagenous matrix form, consisting of collagen Type I chains with other insoluble proteins present.
COLLOSS E is dry with a cotton-like appearance, having a white to slightly yellowish color. The product is processed under aseptic conditions and is nonpyrogenic. It is supplied in a 20 mg quantity, packaged in a vial inside of a Tyvek pouch. The inner surfaces of the pouch are terminally sterilized by plasma sterilization.
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K Number
K053374Device Name
OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)
Manufacturer
OSSACUR AG
Date Cleared
2006-02-21
(78 days)
Product Code
LYC, LPK
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
OSSACUR AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OSSAPLAST DENTAL is intended for use in filling, augmenting, or reconstructing periodontal or bony defects of the oro-maxillofacial region. It is recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of 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 GBR.
Device Description
OSSAPLAST DENTAL is a synthetic, implantable, resorbable, radiopaque βtricalcium phosphate (β-ΤCP) ceramic in granulate form. It consists of purephase β-ΤCP [Саз(РОд)½] and is csteoconductive, with high interconnecting porosity. OSSAPLAST DENTAL is supplied sterile in sealed glass vials, in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.
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K Number
K050416Device Name
OSSAPLAST ORTHO
Manufacturer
OSSACUR AG
Date Cleared
2005-03-29
(39 days)
Product Code
MQV, MOV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
OSSACUR AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, illium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.
Device Description
OSSAPLAST ORTHO (1000 – 2000 µm) is a synthetic, implantable, resorbable, radiopaque β-tricalcium phosphate (β-ΤCP) ceramic in granulate form. It consists of pure-phase β-ΤСР [Саз(РОд)չ] and is osteoconductive, with high interconnecting porosity. OSSAPLAST ORTHO (1000 – 2000 µm) is supplied sterile in sealed glass vials, in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.
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K Number
K042305Device Name
OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903
Manufacturer
OSSACUR AG
Date Cleared
2004-10-21
(57 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
OSSACUR AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.
Device Description
OSSAPLAST ORTHO is a synthetic, implantable, resorbable, radiopaque ß-tricalcium phosphate (β-ΤCP) ceramic in granulate form (particle size of 500 - 1000 µm). It consists of pure-phase ß-TCP [Ca3(PO4)2] and is osteoconductive, with high interconnecting porosity. OSSAPLAST ORTHO is supplied sterile in sealed glass vials in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.
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