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510(k) Data Aggregation
K Number
K110955Device Name
ANYRIDGE INTERNAL IMPLANT SYSTEM
Manufacturer
MEGAGEN CO., LTD.
Date Cleared
2011-11-22
(231 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
MEGAGEN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function: Smaller implants (less than ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
Device Description
The AnyRidge Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form, rootform endosseous dental implant. The AnyRidge Internal Implant System contains two types of fixtures, Normal ridge type and low ridge type, various abutments and instruments. This system is made from pure titanium and the surface treatment is done with R.B.M. The implants are used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of due to deficiency in implant operation. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw (for UCLA abutments) and cement (for solid abutments) retained restoration for multi-mount options. This system has 4.0, 4.4, 4.9, 5.4, 5.9mm diameters for normal ridge and 6.4, 6.9, 7.4, 7.9, 8.4mm diameters for low ridge fixtures. In addition, this system has 7.7, 9.2, 10.7, 12.2, 14.20, 17.20mm lengths for normal ridge and 7.9, 9.4, 10.9, 12.4, 14.4mm lengths for low ridge fixtures.
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K Number
K101890Device Name
BALL ABUTMENT SYSTEM
Manufacturer
MEGAGEN CO., LTD.
Date Cleared
2011-02-03
(211 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
MEGAGEN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ball Abutment Systems are used for implant retained mucosa-supported restorations, such as overdentures where the patient is fully edentulous in the arch to be restored. There are two types of Ball Abutment system, internal and external type, and the ball abutment technique is used on Ball Abutment System implants in the maxilla or mandible.
Device Description
The abutments with the following diameters are available in sizes of 2.85mm, 3.10mm, 5.00mm, and 6.00mm. The male part for each diameter is available in gingival heights of 2.0mm, 4.0mm, and 6.0mm, and the ball head diameter is 2.25mm. There are a total of 15 different size ball abutment systems being offered by Megagen.
External type: The lower part of the Ball Abutment is composed of internal circle so that the external hex of fixture can be inserted. It can combine with screw to be fixed. The top part of the abutment is ball type, and the ball head diameter is 2.25mm, and it is designed to be able to connect with Dalbo Plus which is fixed on overdenture.
Internal type: This type of abutment is inserted and combined with fixture in order to support the overdenture. The sides of lower part of the abutment have been constructed with an 11° so that they can contact with upper part of the inner fixture. The top part of the abutment is designed as a ball type, and the ball head diameter is 2.25mm. This type of design enables to be connected with Dalbo Plus, overdenture.
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K Number
K073058Device Name
RESCUE INTERNAL IMPLANT SYSTEM
Manufacturer
MEGAGEN CO., LTD.
Date Cleared
2008-04-11
(164 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
MEGAGEN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rescue Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, These implants are bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.
Device Description
Rescue Internal Implant System consists of machined titanium, screw-form, root-form endosseous dental implants. It is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.
Rescue Internal Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue Internal Implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, and the instruments.
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K Number
K070562Device Name
EZ PLUS IMPLANT SYSTEM
Manufacturer
MEGAGEN CO., LTD.
Date Cleared
2007-05-18
(80 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
MEGAGEN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EZ Plus Implant Systems are intended to be surgically placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. Large angle abutments (e.g. 25°) on small diameter implants of the EZ Plus internal connection system are intended for the anterior region of the mouth and not intended for use in the posterior region of the mouth due to limited strength of the implant.
Device Description
The EZ Plus Implant system consists of machined titanium, screw-form, root-form endosseous dental implant. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw (for UCLA abutments) and cement (for solid abutments) retained restoration for multi-mount options. Fixtures, the prosthetics, and the surgical instruments are produced and packaged separately. All included devices in the system are covered by this submission.
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K Number
K063216Device Name
RESCUE INTERNAL IMPLANT SYSTEM
Manufacturer
MEGAGEN CO., LTD.
Date Cleared
2007-04-02
(160 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
MEGAGEN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rescue Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.
Device Description
Rescue Internal Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue Internal Implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, and the instruments.
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K Number
K053353Device Name
RESCUE IMPLANT SYSTEM
Manufacturer
MEGAGEN CO., LTD.
Date Cleared
2006-04-19
(138 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
MEGAGEN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rescue® Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.
Device Description
Rescue® Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue® implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, which provide the clinician with screw and cement retained restoration for multi-mount, screw retained restoration for octa abutment, and cement retained restoration for solid abutment restorative options. The devices covered by this submission are Rescue® Implant Fixtures, Retained Restoration Abutment System.
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K Number
K053354Device Name
INTERMEZZO PLUS FIXTURE
Manufacturer
MEGAGEN CO., LTD.
Date Cleared
2006-04-13
(132 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
MEGAGEN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intermezzo ™ Plus are designed for use in dental implant surgery and are intended to be used in a manner in which the implants integrate with the bone (osseointegration). The system is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures.
Device Description
Intermezzo ™ Plus Implant System is an integrated system of endosseous dental implants which are intended for use in partially or fully edentulous mandibles and maxillae in support of overdentures.
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K Number
K052369Device Name
EXFEEL IMPLANT SYSTEM
Manufacturer
MEGAGEN CO., LTD.
Date Cleared
2006-01-10
(134 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
MEGAGEN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ExFeel Dental Implant Systems are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure
Device Description
The ExFeel® Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. ExFeel® implant Fixture Systems consist of one-stage, rootform dental implants, associated with abutment systems, which provide the clinician with screw and cement retained restoration for multi-mount, screw retained restoration for octa abutment, and cement retained restoration for solid abutment restorative options. The devices covered by this submission are ExFeel® Implant Fixtures, Retained Restoration Abutment System.
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K Number
K051018Device Name
INTERMEZZO IMPLANT SYSTEMS
Manufacturer
MEGAGEN CO., LTD.
Date Cleared
2005-09-02
(134 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
MEGAGEN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intermezzo TM Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
Device Description
Intermezzo ™ Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Intermezzo ™ Implant System consists of Intermezzo ™ Implant Fixtures, Intermezzo Cap, and Implant System Surgery Tray. Implant Fixture Systems consist of one-stage, root-form dental implants, associated with protective cap, which provide the clinician to maintain the patients' gingival contour. The system also includes surgical and restorative instrumentation: lance drills, twist drills, unification drills, and handpiece drivers and hand drivers to provide the clinician to choose only those components required for each clinical situation. The devices covered by this submission are Intermezzo ™ Implant Fixtures, Intermezzo Protective Cap, and Intermezzo Implant System Surgery Tray.
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