FDA.reportPublic FDA data

Pectoral Implant

Primary DI
B4905003016
Brand
Pectoral Implant
Company
Aart
Model
E
Catalog number
500-301-6
Device description
Pectoral Style 3 Size 1 Right
Published
2025-08-29
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
MICImplant, Muscle, Pectoralis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MICImplant, Muscle, PectoralisEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021337000AART PECTORALIS IMPLANTAesthetic and Reconstructive Technologies, Inc.2002-07-03MIC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B4905003016PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pectoral implantAn implantable device designed for cosmetic augmentation (submuscular implantation) or reconstruction (e.g., to correct injuries/congenital absence) of the pectoral muscle(s). It is a preshaped (e.g., convex/concave oval-shaped) device typically composed of silicone elastomer.

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
B4905002016Pectoral ImplantAartMIC2025-08-29
B49050020163Pectoral ImplantAartMIC2025-08-29
B4905002025Pectoral ImplantAartMIC2025-08-29
B4905002026Pectoral ImplantAartMIC2025-08-29
B4905002035Pectoral ImplantAartMIC2025-08-29
B4905002036Pectoral ImplantAartMIC2025-08-29
B4905003015Pectoral ImplantAartMIC2025-08-29
B4905003025Pectoral ImplantAartMIC2025-08-29
B4905003026Pectoral ImplantAartMIC2025-08-29
B4905004015Pectoral ImplantAartMIC2025-08-29
B4905004016Pectoral ImplantAartMIC2025-08-29
B4905004025Pectoral ImplantAartMIC2025-08-29
B4905004026Pectoral ImplantAartMIC2025-08-29
B4905004035Pectoral ImplantAartMIC2025-08-29
B4905004036Pectoral ImplantAartMIC2025-08-29
B4905004045Pectoral ImplantAartMIC2025-08-29
B4905004046Pectoral ImplantAartMIC2025-08-29
B4905001015Pectoral ImplantAartMIC2025-08-28
B4905001016Pectoral ImplantAartMIC2025-08-28
B4905001025Pectoral ImplantAartMIC2025-08-28
B4905001026Pectoral ImplantAartMIC2025-08-28
B4905001035Pectoral ImplantAartMIC2025-08-28
B4905001036Pectoral ImplantAartMIC2025-08-28
B4905001045Pectoral ImplantAartMIC2025-08-28
B4905001046Pectoral ImplantAartMIC2025-08-28
B4905001055Pectoral ImplantAartMIC2025-08-28
B4905001056Pectoral ImplantAartMIC2025-08-28
B4905001065Pectoral ImplantAartMIC2025-08-28
B4905001066Pectoral ImplantAartMIC2025-08-28
B4905002005Pectoral ImplantAartMIC2025-08-28