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510(k) Data Aggregation
K Number
K103089Device Name
SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS
Manufacturer
MIS - IMPLANT TECHNOLOGIES LTD.
Date Cleared
2011-09-15
(331 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
MIS - IMPLANT TECHNOLOGIES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MIS dental implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.
MIS short implants are to be used only with straight abutments.
Device Description
The MIS short implants are self tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function.
The MIS short implants are provided in 6.0mm length and 4.2mm, 5.0 mm, and 6.0mm diameters, as follows:
Seven internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
Biocom internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
Lance internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
The implants surface is sand blasted and acid etched.
The MIS short implants are two piece devices whereas the implant is to be used in combination with cover screws, healing caps, abutments and superstructures.
The MIS short implants are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.
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K Number
K080458Device Name
MIS CREST WIDENER
Manufacturer
MIS - IMPLANT TECHNOLOGIES LTD.
Date Cleared
2008-12-17
(301 days)
Product Code
MQN
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
MIS - IMPLANT TECHNOLOGIES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation. The device is used temporary and is removed after the treatment has been completed. The device is for single use only.
Device Description
The MIS crest widener is used to widen a narrow alveolar crest which has sufficient height so as to prepare the ridge for implantation. With this technique. bone augmentation is avoided and the implant is placed in the correct lateral position. The Crest widener is made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02. The device consists of 4 arms, 2 on each side, connected with guiding pins and an activating screw. The Crest Widener is inserted after cutting 3 mucoperiosteal incisions (without stripping the bone) cutting and splitting the narrow alveolar crest. By rotating the activating screw, each pair of arms moves apart from the other 2 arms, thus pushing the buccal cortical bone apart. The device is supplied with a fine Titanium ligature for attachment to a neighbor tooth during the treatment period. Activating starts 5 - 7 days (latency period) after the insertion of the device. By separating the cortical plates, new bone is created in between (Distraction Osteogenesis). The device is not provided sterile and should be sterilized before use.
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K Number
K040807Device Name
MIS DENTAL IMPLANT SYSTEM
Manufacturer
MIS - IMPLANT TECHNOLOGIES LTD.
Date Cleared
2004-06-09
(72 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
MIS - IMPLANT TECHNOLOGIES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MIS 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.
Device Description
The MIS Dental Implant System consists of one and two stage implants, internal and external hexagonal; cover screw and healing caps; abutment systems and suprastructures; surgical instruments.
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