Malar Implant 401-102-5

GUDID B4904011025

Malar Style 1 Size 2 Left

Aart

Malar prosthesis

• Primary Device ID: B4904011025
• NIH Device Record Key: fa0937eb-3a9b-4d94-97ff-67f4ca7da1c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Malar Implant
• Version Model Number: D
• Catalog Number: 401-102-5
• Company DUNS: 091356894
• Company Name: Aart
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B4904011025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021419

FDA Product Code

• LZK: Implant, Malar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[B4904011025]

Dry Heat Sterilization

[B4904011025]

Dry Heat Sterilization

[B4904011025]

Dry Heat Sterilization

[B4904011025]

Dry Heat Sterilization

[B4904011025]

Dry Heat Sterilization

[B4904011025]

Dry Heat Sterilization

[B4904011025]

Dry Heat Sterilization

[B4904011025]

Dry Heat Sterilization

[B4904011025]

Dry Heat Sterilization

[B4904011025]

Dry Heat Sterilization

[B4904011025]

Dry Heat Sterilization

[B4904011025]

Dry Heat Sterilization

[B4904011025]

Dry Heat Sterilization

[B4904011025]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-05
• Device Publish Date: 2025-08-28

On-Brand Devices [Malar Implant]

• B4904012026: Malar Style 2 Size 2 Right
• B4904012025: Malar Style 2 Size 2 Left
• B4904012016: Malar Style 2 Size 1 Right
• B4904012015: Malar Style 2 Size 1 Left
• B4904011036: Malar Style 1 Size 3 Right
• B4904011035: Malar Style 1 Size 3 Left
• B4904011026: Malar Style 1 Size 2 Right
• B4904011025: Malar Style 1 Size 2 Left
• B4904011016: Malar Style 1 Size 1 Right
• B4904011015: Malar Style 1 Size 1 Left