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 Dental appliance fabrication material, cured Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin

• 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