Good Fit Denture Teeth

GUDID 00817610020201

Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU4 - A2

GOOD FIT TECHNOLOGIES, LLC

Resin artificial teeth

• Primary Device ID: 00817610020201
• NIH Device Record Key: fbaa0739-bb99-4c8a-b25f-cebaa85f0da6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Good Fit Denture Teeth
• Version Model Number: 817610020201
• 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	00817610020201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931162

FDA Product Code

• ELM: Denture, Plastic, Teeth

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-09

On-Brand Devices [Good Fit Denture Teeth]

• 00817610020461: Good Fit Denture Teeth - Set (8 Teeth) - Lower Posterior - GP3 - B1
• 00817610020454: Good Fit Denture Teeth - Set (8 Teeth) - Lower Posterior - GP2 - B1
• 00817610020447: Good Fit Denture Teeth - Set (8 Teeth) - Lower Posterior - GP1 - B1
• 00817610020430: Good Fit Denture Teeth - Set (8 Teeth) - Upper Posterior - GP3 - B1
• 00817610020423: Good Fit Denture Teeth - Set (8 Teeth) - Upper Posterior - GP2 - B1
• 00817610020416: Good Fit Denture Teeth - Set (8 Teeth) - Upper Posterior - GP1 - B1
• 00817610020409: Good Fit Denture Teeth - Set (6 Teeth) - Lower Anterior - GL5 - B1
• 00817610020393: Good Fit Denture Teeth - Set (6 Teeth) - Lower Anterior - GL3 - B1
• 00817610020386: Good Fit Denture Teeth - Set (6 Teeth) - Lower Anterior - GL1 - B1
• 00817610020379: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU6 - B1
• 00817610020362: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU5 - B1
• 00817610020355: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU4 - B1
• 00817610020348: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU3 - B1
• 00817610020331: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU2 - B1
• 00817610020324: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU1 - B1
• 00817610020317: Good Fit Denture Teeth - Set (8 Teeth) - Lower Posterior - GP3 - A2
• 00817610020300: Good Fit Denture Teeth - Set (8 Teeth) - Lower Posterior - GP2 - A2
• 00817610020294: Good Fit Denture Teeth - Set (8 Teeth) - Lower Posterior - GP1 - A2
• 00817610020287: Good Fit Denture Teeth - Set (8 Teeth) - Upper Posterior - GP3 - A2
• 00817610020270: Good Fit Denture Teeth - Set (8 Teeth) - Upper Posterior - GP2 - A2
• 00817610020263: Good Fit Denture Teeth - Set (8 Teeth) - Upper Posterior - GP1 - A2
• 00817610020256: Good Fit Denture Teeth - Set (6 Teeth) - Lower Anterior - GL5 - A2
• 00817610020249: Good Fit Denture Teeth - Set (6 Teeth) - Lower Anterior - GL3 - A2
• 00817610020232: Good Fit Denture Teeth - Set (6 Teeth) - Lower Anterior - GL1 - A2
• 00817610020225: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU6 - A2
• 00817610020218: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU5 - A2
• 00817610020201: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU4 - A2
• 00817610020195: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU3 - A2
• 00817610020188: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU2 - A2
• 00817610020171: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU1 - A2
• 00817610020164: Good Fit Denture Teeth - Set (8 Teeth) - Lower Posterior - GP3 - A1
• 00817610020157: Good Fit Denture Teeth - Set (8 Teeth) - Lower Posterior - GP2 - A1
• 00817610020140: Good Fit Denture Teeth - Set (8 Teeth) - Lower Posterior - GP1 - A1
• 00817610020133: Good Fit Denture Teeth - Set (8 Teeth) - Upper Posterior - GP3 - A1
• 00817610020126: Good Fit Denture Teeth - Set (8 Teeth) - Upper Posterior - GP2 - A1
• 00817610020119: Good Fit Denture Teeth - Set (8 Teeth) - Upper Posterior - GP1 - A1
• 00817610020102: Good Fit Denture Teeth - Set (6 Teeth) - Lower Anterior - GL5 - A1
• 00817610020096: Good Fit Denture Teeth - Set (6 Teeth) - Lower Anterior - GL3 - A1
• 00817610020089: Good Fit Denture Teeth - Set (6 Teeth) - Lower Anterior - GL1 - A1
• 00817610020072: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU6 - A1
• 00817610020065: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU5 - A1
• 00817610020058: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU4 - A1
• 00817610020041: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU3 - A1
• 00817610020034: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU2 - A1
• 00817610020027: Good Fit Denture Teeth - Set (6 Teeth) - Upper Anterior - GU1 - A1