Vericore ZR Pro ML 74513

GUDID D040745131

Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate; - Zirconia Substructures - Restorations (Including inlays, onlays, and veneers) - Crown Framework in the Anterior and Posterior regions - Bridge Framework in the Anterior and Posterior regions

WHIP-MIX CORPORATION

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• Primary Device ID: D040745131
• NIH Device Record Key: 24a610a9-a2c3-4fed-a7c1-e0d8d0c2c5b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vericore ZR Pro ML
• Version Model Number: 74513
• Catalog Number: 74513
• Company DUNS: 006385173
• Company Name: WHIP-MIX CORPORATION
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter
• Width: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D040745131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140877

FDA Product Code

• EIH: Powder, Porcelain

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: 2019-05-13
• Device Publish Date: 2019-05-03

On-Brand Devices [Vericore ZR Pro ML]

• D040745911: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745901: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745871: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745601: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745581: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745541: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745531: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745511: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745331: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745321: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745301: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745261: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745251: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745241: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745201: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745191: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745171: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745131: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745121: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D040745101: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C
• D0405611: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with C