Glasgold Wafer™ For EAC or TEAC GLE-2

GUDID M724GLE21

Chin Implant

IMPLANTECH ASSOCIATES, INC.

Chin prosthesis

• Primary Device ID: M724GLE21
• NIH Device Record Key: c7167e03-26c8-4c56-987b-f644ac0e0b2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glasgold Wafer™ For EAC or TEAC
• Version Model Number: GLE-2
• Catalog Number: GLE-2
• 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	M724GLE21 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921581

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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