Upcera

GUDID 06970596160027

Liaoning Upcera Co.,Ltd.

Dental appliance fabrication material, ceramic

• Primary Device ID: 06970596160027
• NIH Device Record Key: 457dcdb1-39a6-42db-b23f-8c54be4c90c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Upcera
• Version Model Number: 20-14-15
• Company DUNS: 548214192
• Company Name: Liaoning Upcera Co.,Ltd.
• Device Count: 12
• 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: true
• 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	06970596160003 [Unit of Use]
GS1	06970596160027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141724

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-04
• Device Publish Date: 2016-10-31

On-Brand Devices [Upcera]

• 06970596166340: Dental Zirconia Blank For Aesthetic Restoration
• 06970596161277: Dental Zirconia Pre-Shaded Blank
• 06970596161260: Dental Zirconia Pre-Shaded Blank
• 06970596161253: Dental Zirconia Pre-Shaded Blank
• 06970596161000: Dental Zirconia Pre-Shaded Blank
• 06970596160997: Dental Zirconia Pre-Shaded Blank
• 06970596160980: Dental Zirconia Pre-Shaded Blank
• 06970596160973: Dental Zirconia Pre-Shaded Blank
• 06970596160966: Dental Zirconia Pre-Shaded Blank
• 06970596160959: Dental Zirconia Pre-Shaded Blank
• 06970596160942: Dental Zirconia Pre-Shaded Blank
• 06970596160935: Dental Zirconia Pre-Shaded Blank
• 06970596160928: Dental Zirconia Pre-Shaded Blank
• 06970596160591: Dental Zirconia Blank
• 06970596160584: Dental Zirconia Blank
• 06970596160577: Dental Zirconia Blank
• 06970596160560: Dental Zirconia Blank
• 06970596160553: Dental Zirconia Blank
• 06970596160546: Dental Zirconia Blank
• 06970596160539: Dental Zirconia Blank
• 06970596160522: Dental Zirconia Blank
• 06970596160515: Dental Zirconia Blank
• 06970596160256: Dental Zirconia Blank
• 06970596160249: Dental Zirconia Blank
• 06970596160232: Dental Zirconia Blank
• 06970596160225: Dental Zirconia Blank
• 06970596160218: Dental Zirconia Blank
• 06970596160201: Dental Zirconia Blank
• 06970596160195: Dental Zirconia Blank
• 06970596160188: Dental Zirconia Blank
• 06970596160096: 85-40-22
• 06970596160089: 65-40-22
• 06970596160072: 65-25-22
• 06970596160065: 55-19-15
• 06970596160058: 40-19-15
• 06970596160041: 40-14-15
• 06970596160034: 20-19-15
• 06970596160027: 20-14-15
• 06970596160010: 14-13-13