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Found 20 results
510(k) Data Aggregation
K Number
K021419Device Name
AART MALAR IMPLANT
Manufacturer
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
Date Cleared
2002-07-02
(60 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Product Code :
LZK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the AART Malar Implant is for augmentation or reconstruction of the check areas of the face.
Device Description
The AART Malar Implants are manufactured from a medical grade silicone elastomer that has been molded into various crescent shaped concave convex implants. They are provided in four styles in pairs of right and left mirror images with dimensions varying in length, width, and height. The AART Malar Implants are intended to be used for augmentation and reconstruction of the cheek areas of the face. The surface characteristic of the implants is smooth, The AART Malar Implants will be offered sterile and non-sterile.
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K Number
K002886Device Name
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
Manufacturer
IMPLANTECH ASSOCIATES, INC.
Date Cleared
2000-11-24
(70 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Product Code :
LZK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992240Device Name
PILLAR MALAR IMPLANT
Manufacturer
PILLAR SURGICAL, INC.
Date Cleared
1999-11-22
(143 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Product Code :
LZK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Each Pillar Malar Implant is indicated for the augmentation or reconstruction of malar eminence deficiencies, whether congenital or acquired by trauma or disease.
Device Description
The Pillar Malar Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that equivalent materials will be used in manufacturing. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.
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K Number
K983756Device Name
SURGIFORM ANATOMICAL MALAR
Manufacturer
SURGICAL TECHNOLOGY LABORATORIES, INC.
Date Cleared
1998-11-20
(29 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Product Code :
LZK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgiform Anatomical Malar implants can be used by surgeons in a unique surgical procedure designed to restore or enhance a patients facial appearance. The implants can be used for aesthetic or reconstructive procedures. The implants can be inserted into a "pocket" created by means of a standard intraoral surgical incision. The implants can elevate and reposition sagging skin and can also fill the hollows and depressions caused by gravity and time. The implants can also be used by surgeons to restore a patients natural appearance as a result of severe facial trauma.
Device Description
Not Found
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K Number
K982763Device Name
SEARE BIOMEDICAL MALAR IMPLANTS
Manufacturer
SEARE BIOMEDICAL CORP.
Date Cleared
1998-09-30
(55 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Product Code :
LZK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Seare Biomedical Malar Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery.
Device Description
Seare Biomedical Malar implants are crescent shaped convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. They are manufactured in pairs with a mirror image left and right. Surface characteristics will varying degrees of texturing and porosity. Seare Biomedical Malar Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery. The Seare Biomedical Malar Implants will be produced using standard manufacturing molding techniques. The Searc Biomedical Malar Implants will be available in many sizes and styles, all of which are very similar - differing only by a few millimeters in length and projection. The Searc Biomedical Malar Implants will be provided sterile and nonsterile.
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K Number
K981835Device Name
SILIMED MALAR IMPLANT
Manufacturer
SILIMED, LLC.
Date Cleared
1998-07-09
(44 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Product Code :
LZK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silimed Malar Implant is designed to be used for augmentation and reconstruction of the cheek.
Device Description
Not Found
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K Number
K980139Device Name
SPECTRUM DESIGNS PROFILE MALAR IMPLANT
Manufacturer
SPECTRUM DESIGNS, INC.
Date Cleared
1998-03-03
(47 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Product Code :
LZK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectrum Designs Profile Malar Implant is intended to augment or reconstruct the malar region of the face.
Device Description
Spectrum Designs Profile Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.
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K Number
K980140Device Name
SPECTRUM DESIGNS MEDIAL MALAR IMPLANT
Manufacturer
SPECTRUM DESIGNS, INC.
Date Cleared
1998-03-03
(47 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Product Code :
LZK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectrum Designs Medial Malar Implant is intended to augment or reconstruct the malar region of the face.
Device Description
Spectrum Designs Medial Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.
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K Number
K980141Device Name
SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
Manufacturer
SPECTRUM DESIGNS, INC.
Date Cleared
1998-03-03
(47 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Product Code :
LZK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectrum Designs Projection Malar Implant is intended to augment or reconstruct the malar region of the face.
Device Description
Spectrum Designs Projection Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.
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K Number
K973502Device Name
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
Manufacturer
IMPLANTECH ASSOCIATES, INC.
Date Cleared
1997-11-07
(52 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Product Code :
LZK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Implantech Conform™ Combined Submalar® Implant is indicated for implantation to augment or reconstruct the underdeveloped or traumatized malar region of the face. The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.
Device Description
The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.
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