Good Fit Denture Base Acrylic

GUDID 00817610025022

Good Fit Denture Base Acrylic - High Impact - DV - 2.5kg

GOOD FIT TECHNOLOGIES, LLC

Dental appliance fabrication material, cured

• Primary Device ID: 00817610025022
• NIH Device Record Key: 755327f3-be9f-4e9e-af6a-3c3842d68b44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Good Fit Denture Base Acrylic
• Version Model Number: 817610025022
• Company DUNS: 080341158
• Company Name: GOOD FIT TECHNOLOGIES, LLC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817610025022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102874

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-24

On-Brand Devices [Good Fit Denture Base Acrylic]

• 00817610025022: Good Fit Denture Base Acrylic - High Impact - DV - 2.5kg
• 00817610023349: Good Fit Denture Base Acrylic - High Impact - 2.5kg
• 00817610023332: Good Fit Denture Base Acrylic - High Impact - 0.5kg