Dental Zirconia Pre-Shaded Blank

GUDID 06970596164735

Liaoning Upcera Co.,Ltd.

Dental appliance fabrication material, ceramic

• Primary Device ID: 06970596164735
• NIH Device Record Key: 5943717a-bf03-4758-b175-4dd8e573416b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Zirconia Pre-Shaded Blank
• Version Model Number: S-C4-R(20-19-15)
• 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	06970596164735 [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: 2
• Public Version Date: 2019-11-04
• Device Publish Date: 2019-04-02

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

• 06970596161826: S-A3.5-R(85-40-22)
• 06970596161819: S-A3.5-R(65-40-22)
• 06970596161802: S-A3.5-R(65-25-22)
• 06970596161796: S-A3.5-R(55-19-15)
• 06970596161789: S-A3.5-R(40-19-15)
• 06970596161772: S-A3.5-R(40-14-15)
• 06970596161765: S-A3.5-R(20-19-15)
• 06970596161758: S-A3.5-R(20-14-15)
• 06970596161499: S-A3-R(85-40-22)
• 06970596161482: S-A3-R(65-40-22)
• 06970596161475: S-A3-R(65-25-22)
• 06970596161468: S-A3-R(55-19-15)
• 06970596161451: S-A3-R(40-19-15)
• 06970596161444: S-A3-R(40-14-15)
• 06970596161437: S-A3-R(20-19-15)
• 06970596161420: S-A3-R(20-14-15)
• 06970596161161: S-A2-R(85-40-22)
• 06970596161154: S-A2-R(65-40-22)
• 06970596161147: S-A2-R(65-25-22)
• 06970596161130: S-A2-R(55-19-15)
• 06970596161123: S-A2-R(40-19-15)
• 06970596161116: S-A2-R(40-14-15)
• 06970596161109: S-A2-R(20-19-15)
• 06970596161093: S-A2-R(20-14-15)
• 06970596160836: S-A1-R(85-40-22)
• 06970596160829: S-A1-R(65-40-22)
• 06970596160812: S-A1-R(65-25-22)
• 06970596160805: S-A1-R(55-19-15)
• 06970596160799: S-A1-R(40-19-15)
• 06970596160782: S-A1-R(40-14-15)
• 06970596160775: S-A1-R(20-19-15)
• 06970596160768: S-A1-R(20-14-15)
• 06970596163660: S-B4-D(100-12)
• 06970596163653: S-B4-D(100-10)
• 06970596163554: S-B4-D(95-25)
• 06970596163479: S-B4-R(85-40-22)
• 06970596163462: S-B4-R(65-40-22)
• 06970596163455: S-B4-R(65-25-22)
• 06970596163448: S-B4-R(55-19-15)
• 06970596163431: S-B4-R(40-19-15)
• 06970596163424: S-B4-R(40-14-15)
• 06970596163417: S-B4-R(20-19-15)
• 06970596163400: S-B4-R(20-14-15)
• 06970596163141: S-B3-R(85-40-22)
• 06970596163134: S-B3-R(65-40-22)
• 06970596163127: S-B3-R(65-25-22)
• 06970596163110: S-B3-R(55-19-15)
• 06970596163103: S-B3-R(40-19-15)
• 06970596163097: S-B3-R(40-14-15)
• 06970596163080: S-B3-R(20-19-15)