UltraPrint-Dental Denture UV

GUDID 00850026127072

1000g, UltraPrint-Dental Denture UV- Pink

Heygears Inc.

Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured 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 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: 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