Lateral Mandibular Angle™ TMA-04-12R

GUDID M724TMA0412R1

Mandibular Implant

IMPLANTECH ASSOCIATES, INC.

Facial mandibular prosthesis Facial mandibular prosthesis Facial mandibular prosthesis Facial mandibular prosthesis Facial mandibular prosthesis Facial mandibular prosthesis Facial mandibular prosthesis Facial mandibular prosthesis Facial mandibular prosthesis Facial mandibular prosthesis Facial mandibular prosthesis Facial mandibular prosthesis Facial mandibular prosthesis

• Primary Device ID: M724TMA0412R1
• NIH Device Record Key: 5059f0f8-cae2-4462-a735-b1674d7756ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lateral Mandibular Angle™
• Version Model Number: Size: 4/12, Right
• Catalog Number: TMA-04-12R
• 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
• 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	M724TMA0412R1 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-14
• Device Publish Date: 2015-09-24

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