upcera Dental Zirconia Pre-Shaded Blank

GUDID 06970596166005

Liaoning Upcera Co.,Ltd.

Dental appliance fabrication material, ceramic

• Primary Device ID: 06970596166005
• NIH Device Record Key: 5c627ad8-f284-42f6-a6d5-d9744134b556
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: upcera Dental Zirconia Pre-Shaded Blank
• Version Model Number: S-D4-D(100-18)
• 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	06970596166005 [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: 6
• Public Version Date: 2019-11-04
• Device Publish Date: 2017-01-10

On-Brand Devices [upcera Dental Zirconia Pre-Shaded Blank]

• 06970596166036: S-D4-D(100-25)
• 06970596166029: S-D4-D(100-22)
• 06970596166012: S-D4-D(100-20)
• 06970596166005: S-D4-D(100-18)
• 06970596165992: S-D4-D(100-16)
• 06970596165985: S-D4-D(100-14)
• 06970596165978: S-D4-D(100-12)
• 06970596165961: S-D4-D(100-10)
• 06970596165954: S-D4-D(98-30)
• 06970596165947: S-D4-D(98-25)
• 06970596165930: S-D4-D(98-22)
• 06970596165923: S-D4-D(98-20)
• 06970596165916: S-D4-D(98-18)
• 06970596165909: S-D4-D(98-16)
• 06970596165893: S-D4-D(98-14)
• 06970596165886: S-D4-D(98-12)
• 06970596165879: S-D4-D(98-10)
• 06970596165862: S-D4-D(95-25)
• 06970596165855: S-D4-D(95-22)
• 06970596165848: S-D4-D(95-20)
• 06970596165831: S-D4-D(95-18)
• 06970596165824: S-D4-D(95-16)
• 06970596165817: S-D4-D(95-14)
• 06970596165800: S-D4-D(95-12)
• 06970596165794: S-D4-D(95-10)
• 06970596165701: S-D3-D(100-25)
• 06970596165695: S-D3-D(100-22)
• 06970596165688: S-D3-D(100-20)
• 06970596165671: S-D3-D(100-18)
• 06970596165664: S-D3-D(100-16)
• 06970596165657: S-D3-D(100-14)
• 06970596165640: S-D3-D(100-12)
• 06970596165633: S-D3-D(100-10)
• 06970596165626: S-D3-D(98-30)
• 06970596165619: S-D3-D(98-25)
• 06970596165602: S-D3-D(98-22)
• 06970596165596: S-D3-D(98-20)
• 06970596165589: S-D3-D(98-18)
• 06970596165572: S-D3-D(98-16)
• 06970596165565: S-D3-D(98-14)
• 06970596165558: S-D3-D(98-12)
• 06970596165541: S-D3-D(98-10)
• 06970596165534: S-D3-D(95-25)
• 06970596165527: S-D3-D(95-22)
• 06970596165510: S-D3-D(95-20)
• 06970596165503: S-D3-D(95-18)
• 06970596165497: S-D3-D(95-16)
• 06970596165480: S-D3-D(95-14)
• 06970596165473: S-D3-D(95-12)
• 06970596165466: S-D3-D(95-10)