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510(k) Data Aggregation
K Number
K200610Device Name
Customized Contour Implant
Manufacturer
Implantech Associates Inc.
Date Cleared
2020-12-23
(289 days)
Product Code
FWP, KKY, MIB, MIC
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
Implantech Associates Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient, for example facial implants, gluteal implants, calf implants, or pectoralis implants.
Device Description
The Customized Contour Implant is a patient-matched device intended for augmentation, reconstructive and cosmetic surgery. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon.
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K Number
K191130Device Name
Customized Contour Implant
Manufacturer
Implantech Associates Inc.
Date Cleared
2019-08-23
(116 days)
Product Code
FWP, KKY
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
Implantech Associates Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.
Device Description
The Customized Contour Implant is a patient-matched for augmentation, reconstructive and cosmetic surgery of the facial regions, specifically the nasal contour, the malar cheek contour, and the chin contour. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon.
The patient's own medical imaging (e.g., Computerized Tomography (CT) scan) is translated into a digital model of the patient's skull using VSP® Software from 3D Systems. At the recommendation of the surgeon, the VSP® Software is used either to 3D-print a skull model for the surgeon to fashion a solid implant model with commercially available plaster or silicon kits, or to create a digital implant model as an STL file. Implantech Associates manufactures the customized molds from the solid implant model provided by the surgeon, or the digital implant model provided by 3D Systems, using plaster molds or 3D-printed molds as appropriate. The Customized Contour Implant is manufactured from the customized molds and provided to the surgeon, sterile or non-sterile.
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K Number
K172389Device Name
ePTFE-Coated Auricular Implant
Manufacturer
Implantech Associates Inc.
Date Cleared
2018-07-18
(344 days)
Product Code
FZD, FWP, FZE, LZK
Regulation Number
878.3590Why did this record match?
Applicant Name (Manufacturer) :
Implantech Associates Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear.
Device Description
The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear. It is intended to be a long term, single use implant. Implantation of the device by the surgeon produces a contour to reconstruct the patient's outer ear feature. A surgically created "pocket" at the implantation site is made by the surgeon for placement of the device (typically placed on the skeletal feature below the soft muscle tissue). The ePTFE-Coated Auricular is composed of a silicone elastomer core with an outer layer of ePTFE (expanded polytetrafluoroethylene) and is shaped approximately to that of the external ear. The implant comes in nine sizes and the surgeon has the option to trim the implant to fit the patient's need. The implant is provided sterile or non-sterile, as either the "Left" or "Right" side.
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K Number
K141027Device Name
3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP
Manufacturer
IMPLANTECH ASSOCIATES INC.
Date Cleared
2014-07-10
(79 days)
Product Code
FWP, FZE, LZK
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
IMPLANTECH ASSOCIATES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Implantech ePTFE Facial Implants are intended for implantation to augment or reconstruct underdeveloped areas of the face. The devices are available in various chin, nasal, malar and carving block three dimensional shapes all which may be additionally carved to allow the surgeon to further shape the device should additional shaping be desired.
Device Description
The Implantech ePTFE Facial Implants are intended for implantation to augment or reconstruct underdeveloped areas of the face. The devices are available in various chin, nasal, malar and carving block three dimensional shapes all which may be additionally carved to allow the surgeon to further shape the device should additional shaping be desired.
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K Number
K071470Device Name
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
Manufacturer
IMPLANTECH ASSOCIATES INC.
Date Cleared
2007-08-31
(94 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
IMPLANTECH ASSOCIATES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ePTFE Sheeting is intended for use in the augmentation or repair of the soft tissue of the facial area.
Device Description
Not Found
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K Number
K052504Device Name
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
Manufacturer
IMPLANTECH ASSOCIATES INC.
Date Cleared
2005-11-04
(52 days)
Product Code
MIB
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
IMPLANTECH ASSOCIATES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gluteal Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Gluteal Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.
Device Description
Gluteal Implants (Silicone Carving Blocks)
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K Number
K052505Device Name
CALF IMPLANT, MODEL EC17-X
Manufacturer
IMPLANTECH ASSOCIATES INC.
Date Cleared
2005-11-04
(52 days)
Product Code
MIB
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
IMPLANTECH ASSOCIATES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Caff Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Calf Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.
Device Description
Calf Implant (Silicone Carving Blocks)
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