FDA.report

Malar prosthesis

Definition
An implantable device designed to augment or maintain the soft-tissue anatomy of the malar area (cheek). The device is typically a solid elastomer (e.g., silicone) available in several shapes and sizes for subdermal implantation in the malar area for cosmetic or reconstructive purposes following traumatic or disease/congenital deformation. This is a single-use device.
GUDID devices
356
Last updated
2025-09-05 14:12:24

Related Product Codes

CodeDeviceSpecialtyClassDevices
LZKImplant, MalarGeneral, Plastic Surgery2327
FWPProsthesis, Chin, InternalGeneral, Plastic Surgery222
ODUFacial ImplantGeneral, Plastic Surgery26
FZEProsthesis, Nose, InternalGeneral, Plastic Surgery21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
B4904011015Malar ImplantAartD2025-08-28
B4904011016Malar ImplantAartD2025-08-28
B4904011025Malar ImplantAartD2025-08-28
B4904011026Malar ImplantAartD2025-08-28
B4904011035Malar ImplantAartD2025-08-28
B4904011036Malar ImplantAartD2025-08-28
B4904012015Malar ImplantAartD2025-08-28
B4904012016Malar ImplantAartD2025-08-28
B4904012025Malar ImplantAartD2025-08-28
B4904012026Malar ImplantAartD2025-08-28
M724ESPF501Solid ePTFE Paranasal, Flat TopIMPLANTECH ASSOCIATES, INC.size:5mm2024-11-01
M724ESPF701Solid ePTFE Paranasal, Flat TopIMPLANTECH ASSOCIATES, INC.size:7mm2024-11-01
M724ESPS501Solid ePTFE Paranasal, Sharp TopIMPLANTECH ASSOCIATES, INC.Size: 5mm2024-11-01
M7249000101900-010 Anatomical Malar I Sizer SetIMPLANTECH ASSOCIATES, INC.900-0102021-07-20
M7249000111900-011 Anatomical Malar II Sizer SetIMPLANTECH ASSOCIATES, INC.900-0112021-07-20
M7249000121900-012 Extended Malar Sizer SetIMPLANTECH ASSOCIATES, INC.900-0122021-07-20
M7249000131900-013 Combined Malar Sizer SetIMPLANTECH ASSOCIATES, INC.900-0132021-07-20
M7249000141900-014 Profile Malar Sizer SetIMPLANTECH ASSOCIATES, INC.900-0142021-07-20
M724120214S1Anatomical Malar IIMPLANTECH ASSOCIATES, INC.Size 12021-04-13
M724120224S1Anatomical Malar IIMPLANTECH ASSOCIATES, INC.Size 22021-04-13
M724120234S1Anatomical Malar IIMPLANTECH ASSOCIATES, INC.Size 32021-04-13
M724130314S1Anatomical Malar IIIMPLANTECH ASSOCIATES, INC.Size 12021-04-13
M724130324S1Anatomical Malar IIIMPLANTECH ASSOCIATES, INC.Size 22021-04-13
M724130334S1Anatomical Malar IIIMPLANTECH ASSOCIATES, INC.Size 32021-04-13
M724140414S1Profile MalarIMPLANTECH ASSOCIATES, INC.Size 12021-04-13
M724140424S1Profile MalarIMPLANTECH ASSOCIATES, INC.Size 22021-04-13
M724140434S1Profile MalarIMPLANTECH ASSOCIATES, INC.Size32021-04-13
M724140444S1Profile MalarIMPLANTECH ASSOCIATES, INC.Size 42021-04-13
M724150514S1Extended MalarIMPLANTECH ASSOCIATES, INC.Size 12021-04-13
M724150524S1Extended MalarIMPLANTECH ASSOCIATES, INC.Size 22021-04-13
M724150534S1Extended MalarIMPLANTECH ASSOCIATES, INC.Size 32021-04-13
M724160614S1Combined MalarIMPLANTECH ASSOCIATES, INC.Size 12021-04-13
M724160624S1Combined MalarIMPLANTECH ASSOCIATES, INC.Size 22021-04-13
M724160634S1Combined MalarIMPLANTECH ASSOCIATES, INC.Size 32021-04-13
M724BSMIIL1Binder Submalar® IIIMPLANTECH ASSOCIATES, INC.Size: Large2015-09-24
M724BSMM1Binder Submalar®IMPLANTECH ASSOCIATES, INC.Size: Medium2015-09-24
M724BSMS1Binder Submalar®IMPLANTECH ASSOCIATES, INC.Size: Small2015-09-24
M724CBSMS1Conform Binder Submalar®IMPLANTECH ASSOCIATES, INC.Size: Small2015-09-24
M724CTMSL41Conform Terino Malar Shell®IMPLANTECH ASSOCIATES, INC.Size: Large2015-09-24
M724CTMSS41Conform Terino Malar Shell®IMPLANTECH ASSOCIATES, INC.Size: Small2015-09-24
M724EFTTL1Flowers Extended Tear Trough®IMPLANTECH ASSOCIATES, INC.Size: Large2015-09-24
M724EPTFETMSXL1Composite™ ePTFE-Coated Terino Malar Shell®IMPLANTECH ASSOCIATES, INC.Size: X-Large2015-09-24
M724FTTS1Flowers Tear Trough®IMPLANTECH ASSOCIATES, INC.Size: Small2015-09-24
M724M511Malar ImplantIMPLANTECH ASSOCIATES, INC.Style 5 / Size 12015-09-24
M724M611Malar ImplantIMPLANTECH ASSOCIATES, INC.Style 6 / Size 12015-09-24
M724M711Malar ImplantIMPLANTECH ASSOCIATES, INC.Style 7 / Size 12015-09-24
M724M731Malar ImplantIMPLANTECH ASSOCIATES, INC.Style 7 / Size 32015-09-24
M724NLIS1Mittelman Melo-Labial Groove™IMPLANTECH ASSOCIATES, INC.Size: Small2015-09-24
M724NLIXL1Mittelman Melo-Labial Groove™IMPLANTECH ASSOCIATES, INC.Size: X-Large2015-09-24
M724TM11Trapezoidal Malar IMPLANTECH ASSOCIATES, INC.Size: X-Small2015-09-24
M724TM51Trapezoidal Malar IMPLANTECH ASSOCIATES, INC.Size: X-Large2015-09-24
M724TMSXL41Terino Malar Shell® IMPLANTECH ASSOCIATES, INC.Size: X-Large (4mm)2015-09-24
M724TMSXL51Terino Malar Shell® IMPLANTECH ASSOCIATES, INC.Size: X-Large (5mm)2015-09-24
M724ALIL1Arnett Lefort ImplantIMPLANTECH ASSOCIATES, INC.Size: Large2015-09-24
M724ALIM1Arnett Lefort ImplantIMPLANTECH ASSOCIATES, INC.Size: Medium2015-09-24
M724ALIS1Arnett Lefort ImplantIMPLANTECH ASSOCIATES, INC.Size: Small2015-09-24
M724BSMIIM1Binder Submalar® IIIMPLANTECH ASSOCIATES, INC.Size: Medium2015-09-24
M724BSMIIS1Binder Submalar® IIIMPLANTECH ASSOCIATES, INC.Size: Small2015-09-24
M724BSMIIXL1Binder Submalar® IIIMPLANTECH ASSOCIATES, INC.Size: X-Large2015-09-24
M724BSML1Binder Submalar®IMPLANTECH ASSOCIATES, INC.Size: Large2015-09-24
M724BSMXL1Binder Submalar®IMPLANTECH ASSOCIATES, INC.Size: X-Large2015-09-24
M724CBSML1Conform Binder Submalar®IMPLANTECH ASSOCIATES, INC.Size: Large2015-09-24
M724CBSMM1Conform Binder Submalar®IMPLANTECH ASSOCIATES, INC.Size: Medium2015-09-24
M724CBSMXL1Conform Binder Submalar®IMPLANTECH ASSOCIATES, INC.Size: X-Large2015-09-24
M724CCSML1Conform™ Midfacial IMPLANTECH ASSOCIATES, INC.Size: Large2015-09-24
M724CCSMM1Conform™ Midfacial IMPLANTECH ASSOCIATES, INC.Size: Medium2015-09-24
M724CCSMS1Conform™ Midfacial IMPLANTECH ASSOCIATES, INC.Size: Small2015-09-24
M724CCSMXL1Conform™ Midfacial IMPLANTECH ASSOCIATES, INC.Size: X-Large2015-09-24
M724CCSMXS1Conform™ Midfacial IMPLANTECH ASSOCIATES, INC.Size: X-Small2015-09-24
M724CSML1Combined Submalar Shell™IMPLANTECH ASSOCIATES, INC.Size: Large2015-09-24
M724CSMM1Combined Submalar Shell™IMPLANTECH ASSOCIATES, INC.Size: Medium2015-09-24
M724CSMS1Combined Submalar Shell™IMPLANTECH ASSOCIATES, INC.Size: Small2015-09-24
M724CSMXL1Combined Submalar Shell™IMPLANTECH ASSOCIATES, INC.Size: X-Large2015-09-24
M724CTMSM41Conform Terino Malar Shell®IMPLANTECH ASSOCIATES, INC.Size: Medium2015-09-24
M724CTMSXL41Conform Terino Malar Shell®IMPLANTECH ASSOCIATES, INC.Size: X-Large2015-09-24
M724EPTFEBSMIIL1Composite™ ePTFE-Coated Binder Submalar® IIIMPLANTECH ASSOCIATES, INC.Size: Large2015-09-24
M724EPTFEBSMIIM1Composite™ ePTFE-Coated Binder Submalar® IIIMPLANTECH ASSOCIATES, INC.Size: Medium2015-09-24
M724EPTFEBSMIIS1Composite™ ePTFE-Coated Binder Submalar® IIIMPLANTECH ASSOCIATES, INC.Size: Small2015-09-24
M724EPTFEBSMIIXL1Composite™ ePTFE-Coated Binder Submalar® IIIMPLANTECH ASSOCIATES, INC.Size: X-Large2015-09-24
M724EPTFETMSL1Composite™ ePTFE-Coated Terino Malar Shell®IMPLANTECH ASSOCIATES, INC.Size: Large2015-09-24