Lateral Mandibular Angle™ TMA-4R/10

GUDID M724TMA4R101

Mandibular Implant

IMPLANTECH ASSOCIATES, INC.

Facial mandibular prosthesis

• Primary Device ID: M724TMA4R101
• NIH Device Record Key: 236cf03c-24b0-478f-8f42-bd013dbea420
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lateral Mandibular Angle™
• Version Model Number: Size 4/10, Right
• Catalog Number: TMA-4R/10
• 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

Customer Support Contacts

• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724TMA4R101 [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 [Lateral Mandibular Angle™]

• M724TMA0412L1: Mandibular Implant
• M724TMA0410R1: Mandibular Implant
• M724TMA0410L1: Mandibular Implant
• M724TMA0408R1: Mandibular Implant
• M724TMA0408L1: Mandibular Implant
• M724TMA4R81: Mandibular Implants
• M724TMA4R121: Mandibular Implant
• M724TMA4R101: Mandibular Implant
• M724TMA4L81: Mandibular Implant
• M724TMA4L121: Mandibular Implant
• M724TMA4L101: Mandibular Implant