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Found 7 results
510(k) Data Aggregation
K Number
K033815Device Name
BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN
Manufacturer
GEISTLICH-PHARMA
Date Cleared
2004-01-15
(37 days)
Product Code
NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
GEISTLICH-PHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filing of defects after root resection, apicocctomy, and cystectomy Filing 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 Regencration (GTR) and Guided Bone Regencration (GBR).
Filing of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
Device Description
BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are natural non-antigenic, porous bone mineral matrixes. They arc produced by removal of all organic components from bovinc bone. Due to its natural structure, BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are physically and chemically comparable to the mineralized matrix of human bone. It is available as cortical granules and blocks.
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K Number
K014289Device Name
ORTHOSS RESORBABLE BONE VOID FILLER
Manufacturer
GEISTLICH-PHARMA
Date Cleared
2002-03-28
(90 days)
Product Code
LYC, MQV
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
GEISTLICH-PHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ORTHOSS is indicated for bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). ORTHOSS is indicated only for use in bone voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Device Description
ORTHOSS™ Resorbable Bone Void Filler
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K Number
K970569Device Name
BIO-BLOCKS
Manufacturer
GEISTLICH-PHARMA
Date Cleared
2000-08-14
(1294 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
GEISTLICH-PHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Augmentation of reconstructive treatment of the alveolar ridge
Filling of defects after root resection, apicoeccomy and cystectomy
Filling of extraction sockets to enhance preservation of the alveolar ridge
Device Description
Not Found
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K Number
K974399Device Name
BIO-OSS COLLAGEN
Manufacturer
GEISTLICH-PHARMA
Date Cleared
1998-09-16
(299 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
GEISTLICH-PHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Augmentation or reconstructive treatment of alveolar ridge
Filling of periodontal defects
Filling of defects after root resection, apicoectomy, and cystectomy
rilling 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
Not Found
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K Number
K970321Device Name
BIO-OSS ANORGANIC BOVINE BONE
Manufacturer
GEISTLICH-PHARMA
Date Cleared
1998-09-15
(595 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
GEISTLICH-PHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Augmentation or reconstructive treatment of alveolar ridge defects also of any indeasal defects Filling of periodontal defects Filling of defects after root resection, apicoectony, and cyscecomy, and cyscecomy of the also and of and and and and enhance preservarion of- the alveola Filling of defects after root teseccion, approactory, and of the alvestar ridge Elevacion of maxillary sinus floor Filling of periodontal defects in conjunction with products intended for Filling of periodontal defects in conjunector aren production (GBR). Guided Tissue Regeneration(GTR) and Guided Bone Regeneration(GBR). villag of peri-implant defects in conjunction with products intended for the before Bear archier/GRP) Guided Bone Regeneration (GBR)
Device Description
Anorganic Bovine Bone
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K Number
K972817Device Name
RESOR-PIN RESORBABLE MEMBRANE PIN
Manufacturer
GEISTLICH-PHARMA
Date Cleared
1998-07-24
(360 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
GEISTLICH-PHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Resor-Pin is used in oral, dental and maxillofacial surgery and guided bone regeneration.
Device Description
Resor-Pin Resorbable Membrane Pin
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K Number
K960724Device Name
BIO-GIDE RESORBABLE BILAYER MEMBRANE
Manufacturer
GEISTLICH-PHARMA
Date Cleared
1997-06-11
(475 days)
Product Code
NPK
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
GEISTLICH-PHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BIO-GIDE® is indicated for: - simultaneous use GBR-membrane (BIO-GIDE®) and implants: augmentation around implants placed in immediate extract sockets; - augmentation around implants placed in delayed extraction sockets; . - . localized ridge augmentation for later implantation; - alveolar ridge reconstruction for prosthetic treatment - filling of bone defects after root resection, cystectomy, removal of retained teeth. Becayse of its elasticity, BIO-GIDE® has to be used in combination with space-making bone graft materials, e.g., autogenous bone, bone substitutes (BIO-OSS®, etc.)
Device Description
Not Found
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