Temporal Shell™ Implant TS-04L

GUDID M724TS04L1

Temporal Implant

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: M724TS04L1
• NIH Device Record Key: 77b03caa-a7bf-4d0d-b210-2f946fbc4877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Temporal Shell™ Implant
• Version Model Number: Size: 4mm, Left
• Catalog Number: TS-04L
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724TS04L1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943644

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: 2016-04-22

On-Brand Devices [Temporal Shell™ Implant]

• M724TS04L1: Temporal Implant
• M724TS04R1: Temporal Implant