Posterior Mandibular Angle™ TMA-6L

GUDID M724TMA6L1

Mandibular Implant

IMPLANTECH ASSOCIATES, INC.

Facial mandibular prosthesis

• Primary Device ID: M724TMA6L1
• NIH Device Record Key: e91722a8-6d9a-4059-9ee3-9014128da551
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Posterior Mandibular Angle™
• Version Model Number: Size 6, Left
• Catalog Number: TMA-6L
• Company DUNS: 784664955
• Company Name: IMPLANTECH ASSOCIATES, INC.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724TMA6L1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905268

FDA Product Code

• FWP: Prosthesis, Chin, Internal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-28
• Device Publish Date: 2022-03-18

On-Brand Devices [Posterior Mandibular Angle™]

• M724TMA10R1: Mandibular Implant
• M724TMA10L1: Mandibular Implant
• M724TMA08L1: Mandibular Implant
• M724TMA06R1: Mandibular Implant
• M724TMA06L1: Mandibular Implant
• M724TMA04R1: Mandibular Implant
• M724TMA04L1: Mandibular Implant
• M724TMA08R1: Mandibular Implant
• M724TMA8R1: Mandibular Implant
• M724TMA8L1: Mandibular Implant
• M724TMA6R1: Mandibular Implant
• M724TMA6L1: Mandibular Implant
• M724TMA4R1: Mandibular Implants
• M724TMA4L1: Mandibular Implant