FDA.reportPublic FDA data

Malar Implant

Primary DI
B4904012026
Brand
Malar Implant
Company
Aart
Model
D
Catalog number
401-202-6
Device description
Malar Style 2 Size 2 Right
Published
2025-08-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZKImplant, Malar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZKImplant, MalarGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021419000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021419000AART MALAR IMPLANTAesthetic and Reconstructive Technologies, Inc.2002-07-02LZK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B4904012026PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Malar prosthesisAn 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.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
(775) 853-6800customer.service@alphaaesthetics.com

Regulatory Flags#

DUNS number
091356894
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B490100101Dimisil Scar GelA100-1012026-06-04
B490501101Gluteal ImplantE501-1012025-09-02
B490501102Gluteal ImplantE501-1022025-09-02
B490501103Gluteal ImplantE501-1032025-09-02
B490501104Gluteal ImplantE501-1042025-09-02
B490501105Gluteal ImplantE501-1052025-09-02
B4905011053Gluteal ImplantD501-105-32025-09-02
B490501106Gluteal ImplantE501-1062025-09-02
B4905011063Gluteal ImplantD501-106-32025-09-02
B490501201Gluteal ImplantE501-2012025-09-02
B490501202Gluteal ImplantE501-2022025-09-02
B490501203Gluteal ImplantE501-2032025-09-02
B490501204Gluteal ImplantE501-2042025-09-02
B490501205Gluteal ImplantE501-2052025-09-02
B490501206Gluteal ImplantE501-2062025-09-02
B4905012063Gluteal ImplantB501-206-32025-09-02
B490501300Gluteal ImplantE501-3002025-09-02
B4905013003Gluteal ImplantD501-300-32025-09-02
B490501301Gluteal ImplantE501-3012025-09-02
B4905013013Gluteal ImplantD501-301-32025-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M724BSMIISIZNS1Binder Submalar® II SizerIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724BSMSIZNS1Binder Submalar® SizerIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CBSMSIZNS1Conform Binder Submalar® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CCSMSIZNS1Conform Midfacial Implant SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CMASIZNS1Conform Mandibular Angle™ SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CSMSIZNS1Combined Submalar Shell™ SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CTMSSIZNS1Conform Terino Malar Shell® IMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724FTTSIZNS1Flowers Tear Trough® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724TMSSIZNS1Terino Malar Shell® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
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00841036203795HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-08
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00841036203580HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-07
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