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510(k) Data Aggregation
K Number
K972278Device Name
CYTOPLAST REGENTEX TITANIUM 250
Manufacturer
OSTEOGENICS CO.
Date Cleared
1997-08-06
(49 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
OSTEOGENICS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
A temporarily implantable material (non-resorbable) for use as a spacemaking barrier in the treatment of periodontal bone defects.
Device Description
The Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film reinforced with a titanium framework. The membrane has a nominal thickness of 250 microns. Membranes are supplied sterile in sealed pouches in a variety of shapes and sizes.
The biocompatibility of polytetrafluoroethylene (PTFE) and titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been conducted with this device.
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K Number
K964342Device Name
CYTOPLAST GBR
Manufacturer
OSTEOGENICS CO.
Date Cleared
1997-03-11
(131 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
OSTEOGENICS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
Device Description
The Cytoplast™ GBR Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film with a nominal thickness of 250 microns and supplied in a variety of shapes and sizes. Membranes are supplied sterile in sealed pouches.
The biocompatibility of polytetrafluoroethylene (PTFE) has been established through a long history of use in a variety of long-term PTFE implant devices, such as PTFE vascular prostheses and cardiovascular patches. The Cytoplast™ GBR Non-Absorbable Barrier Membrane has been shown to be non-cytotoxic.
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