UltraPrint-Dental Denture UV

GUDID 00850026127072

1000g, UltraPrint-Dental Denture UV- Pink

Heygears Inc.

Dental appliance fabrication material, cured

• Primary Device ID: 00850026127072
• NIH Device Record Key: 93f3b9ad-7ec0-4f8f-8932-beb53b50cda1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraPrint-Dental Denture UV
• Version Model Number: 1.0
• Company DUNS: 111627614
• Company Name: Heygears 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850026127072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200461

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-29
• Device Publish Date: 2021-01-21

Devices Manufactured by Heygears Inc.

• 00850026127072 - UltraPrint-Dental Denture UV: 2021-01-291000g, UltraPrint-Dental Denture UV- Pink
• 00850026127072 - UltraPrint-Dental Denture UV: 2021-01-29 1000g, UltraPrint-Dental Denture UV- Pink
• 00850026127003 - UltraPrint-Dental Temp C&B UV: 2021-01-20 1000g, UltraPrint-Dental Temp C&B UV-A1
• 00850026127010 - UltraPrint-Dental Temp C&B UV: 2021-01-20 500g, UltraPrint-Dental Temp C&B UV-A1
• 00850026127027 - UltraPrint-Dental Temp C&B UV: 2021-01-20 1000g, UltraPrint-Dental Temp C&B UV-A2
• 00850026127034 - UltraPrint-Dental Temp C&B UV: 2021-01-20 500g, UltraPrint-Dental Temp C&B UV-A2
• 00850026127041 - UltraPrint-Dental Temp C&B UV: 2021-01-20 1000g, UltraPrint-Dental Temp C&B UV-A3
• 00850026127058 - UltraPrint-Dental Temp C&B UV: 2021-01-20 500g, UltraPrint-Dental Temp C&B UV-A3