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510(k) Data Aggregation
K Number
K063769Device Name
ALPHA BIO BONE FIXATION SCREW SYSTEM
Manufacturer
ALPHA-BIO TEC LTD
Date Cleared
2007-03-30
(100 days)
Product Code
DZL
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
ALPHA-BIO TEC LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alpha-Bio Bone Fixation Screw System® is used to stabilize and fixate bone grafts, bone filling materials, and / or barrier membranes used for regeneration of bone in the oral cavity. The system includes titanium screws 1.2mmd and 1.6mmd diameter, and drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure.
Device Description
The Alpha-Bio Bone Fixation Screw System consists of titanium alloy Gr-5 screws with 1.2mmd and 1.6mmd diameter, and with 4mm-12mm lengths. This system includes drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure
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K Number
K063770Device Name
ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM
Manufacturer
ALPHA-BIO TEC LTD
Date Cleared
2007-03-26
(96 days)
Product Code
OAT, DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ALPHA-BIO TEC LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Alpha Bio Orthodontic Fixation Screw System® are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
Device Description
Alpha Bio Orthodontic Fixation Screw System® OFS, OFSR consists of titanium alloy Gr-5 mini thread self tapping implants, are available with 1.6 and 2mm diameter and 8, 10, 12 length.
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K Number
K063364Device Name
ALPHA BIO DENTAL IMPLANT SYSTEM
Manufacturer
ALPHA-BIO TEC LTD
Date Cleared
2007-03-14
(127 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ALPHA-BIO TEC LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alpha-Bio Dental Implant System® is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Alpha-Bio Dental Implant System® is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
The Alpha-Bio Dental Implant System® consists of one and two stage endosseous form dental implants, internal and external hexagonal; internal octagonal hexagonal; one piece implants system; cover screws and healing caps; abutment systems and superstructures; surgical instruments.
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