Nacera Pearl Shaded 16+2 3274309838

GUDID EDDI32743098381

The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirconium dioxide (3Y-TZP) are suitable for dental applications of type II, class 5 in accordance with DIN EN ISO 6872 and they fulfill their material-specific requirements after specified final sintering.

Dental Direkt GmbH

Dental appliance fabrication material, ceramic

• Primary Device ID: EDDI32743098381
• NIH Device Record Key: ff0ad503-253b-484f-9a83-fe184a156573
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nacera Pearl Shaded 16+2
• Version Model Number: 98.3x38 C4
• Catalog Number: 3274309838
• Company DUNS: 313214171
• Company Name: Dental Direkt GmbH
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de
• Phone: +495225863190
• Email: qmra@dentaldirekt.de

Device Dimensions

• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter
• Outer Diameter: 98.3 Millimeter
• Height: 38 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDI32743098381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143071

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: 2024-06-05
• Device Publish Date: 2024-05-28

On-Brand Devices [Nacera Pearl Shaded 16+2]

• EDDI32773098381: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32773098251: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32773098181: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32773087871: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32773024241: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32763098381: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32763098251: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32763098181: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32763087871: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32763024241: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32753098381: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32753098251: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32753098181: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32753087871: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32753024241: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32743098381: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32743098251: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32743098181: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32743087871: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32743024241: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32733098381: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32733098251: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32733098181: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32733087871: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32733024241: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32723098381: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32723098251: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32723098181: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32723087871: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32723024241: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32713098381: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32713098251: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32713098181: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32713087871: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32713024241: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32703098381: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32703098251: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32703098181: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32703087871: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32703024241: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32693098381: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32693098251: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32693098181: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32693087871: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32693024241: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32683098381: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32683098251: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32683098181: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32683087871: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco
• EDDI32683024241: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirco