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510(k) Data Aggregation
K Number
K190837Device Name
Internal Hex Implant System
Manufacturer
EBI Inc.
Date Cleared
2020-01-22
(296 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
EBI Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Internal Hex Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. For implant bodies Ø4.1 and greater, the Internal Hex Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implant bodies with a diameter less than Ø4.1 are intended for immediate loading when using a minimum of 4 implants with lengths >8mm.
Device Description
The subject endosseous dental implant bodies are composed of Pure Titanium Grade 4. Internal Hex Implant System has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placements. Internal Hex Implant Systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The Internal Hex Implant System has an internal connection. The surface of the implant bodies has been treated with SLA (Sandblast, Large grit Acid etched). The system consists of BLT II OS Implant Fixtures and various abutments such as Cover Screw, Healing abutment, BestDuo Abutment, BestSolid Abutment, BestOcta Abutment, BestAngled Abutment, Temporary Abutment, Octa Plastic Cylinder, Denture Abutment, Multi-Unit Abutment, Multi-unit Abutment Screw, Multi-Unit Healing Cap, Multi-Unit Temporary Cylinder, Multi-Unit Cylinder Screw and Abutment Screw.
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K Number
K170031Device Name
Internal Octa Implant System
Manufacturer
EBI Inc.
Date Cleared
2017-08-31
(239 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
EBI Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Internal Octa Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The Internal Octa Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
An endosseous dental implant is a device made of Pure Titanium Grade 4. Internal Octa Implant System has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placements. Internal Octa Implant Systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The Internal Octa Implant System has an internal connection. The surface of the system has been treated with SLA (Sandblast, Large grit Acid etched).
There are 3different kinds of fixtures, BLT III, Precision III and LISA Implants. The only differences between these implants are designs and dimensions. The appearance of implants is different depending on the presence of cutting edge and taper. The Fixtures are supplied sterile.
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K Number
K142426Device Name
EBI External Implant System
Manufacturer
EBI Inc
Date Cleared
2015-03-27
(210 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
EBI Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EBI Dental Implant System is intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
Device Description
An endosseous dental implant is a device made of a material such as Pure Titanium Grade 4 and Titanium alloy (Ti-6A1-4V ELI). EBI Implant system has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placement. EBI Implant systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The EBI External Implant System has an external connection.
The surface of the system has been treated with RBM (Resorbable Blasted media).
The Fixture diameters are 3.25, 3.3, 3.75, 4, 4.1, 4.8, 5, 5.5, 6, 6.5, 7mm and lengths are 7, 8, 8.1, 8.5, 9, 9.6, 10, 11, 11.5, 12, 12.6, 13, 14, 14.6, 15mm in this system.
The contained various abutments and accessories in the system are cover screw, healing abutment, cemented abutment, temporary abutment, healing cap, impression coping, analog, fixture mount, Ti-screw, angled abutment, impression guide pin, gold UCLA abutment and locator.
Fixtures and abutments are packaged separately. The Fixtures are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.
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