UltraPrint-Dental Temp C&B UV

GUDID 00850026127041

1000g, UltraPrint-Dental Temp C&B UV-A3

Heygears Inc.

Dental crown/bridge resin, temporary

• Primary Device ID: 00850026127041
• NIH Device Record Key: 3aef5eee-6b4a-4487-b18d-d5b7228318d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraPrint-Dental Temp C&B 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	00850026127041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200273

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2021-01-20
• Device Publish Date: 2021-01-12

On-Brand Devices [UltraPrint-Dental Temp C&B UV]

• 00850026127058: 500g, UltraPrint-Dental Temp C&B UV-A3
• 00850026127041: 1000g, UltraPrint-Dental Temp C&B UV-A3
• 00850026127034: 500g, UltraPrint-Dental Temp C&B UV-A2
• 00850026127027: 1000g, UltraPrint-Dental Temp C&B UV-A2
• 00850026127010: 500g, UltraPrint-Dental Temp C&B UV-A1
• 00850026127003: 1000g, UltraPrint-Dental Temp C&B UV-A1