Upcera Dental Zirconia Blank

GUDID 06970596160324

Liaoning Upcera Co.,Ltd.

Dental appliance fabrication material, ceramic

• Primary Device ID: 06970596160324
• NIH Device Record Key: 6f2d31bd-9904-45dd-b10b-98d33003e9f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Upcera Dental Zirconia Blank
• Version Model Number: D100-22
• Company DUNS: 548214192
• Company Name: Liaoning Upcera Co.,Ltd.
• 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: 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	06970596160324 [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 Dental Zirconia Blank]

• 06970596160751: 89-71-25
• 06970596160744: 89-71-22
• 06970596160737: 89-71-20
• 06970596160720: 89-71-18
• 06970596160713: 89-71-16
• 06970596160706: 89-71-14
• 06970596160690: 89-71-12
• 06970596160683: 89-71-10
• 06970596160676: D100-25
• 06970596160669: D100-22
• 06970596160652: D100-20
• 06970596160645: D100-18
• 06970596160638: D100-16
• 06970596160621: D100-14
• 06970596160614: D100-12
• 06970596160607: D100-10
• 06970596160508: D95-25
• 06970596160492: D95-22
• 06970596160485: D95-20
• 06970596160478: D95-18
• 06970596160461: D95-16
• 06970596160454: D95-14
• 06970596160447: D95-12
• 06970596160430: D95-10
• 06970596160331: D100-25
• 06970596160324: D100-22
• 06970596160317: D100-20
• 06970596160300: D100-18
• 06970596160294: D100-16
• 06970596160287: D100-14
• 06970596160263: D100-10
• 06970596160171: D95-25
• 06970596160164: D95-22
• 06970596160157: D95-20
• 06970596160140: D95-18
• 06970596160133: D95-16
• 06970596160126: D95-14
• 06970596160119: D95-12
• 06970596160102: D95-10
• 06941382252646: 72-42-25
• 06941382252639: 72-42-22
• 06941382252622: 72-42-20
• 06941382252615: 72-42-18
• 06941382252608: 72-42-16
• 06941382252592: 72-42-14
• 06941382252585: 72-42-12
• 06941382252578: 72-42-10
• 06941382252561: 72-42-25
• 06941382252554: 72-42-22
• 06941382252547: 72-42-20