Delta Multilayered Zirconia Translucent

GUDID 00816795024707

98X16mm Multilayered Translucent Zirconia Shade A3.5

AURIDENT INC

Dental porcelain/ceramic restoration kit

• Primary Device ID: 00816795024707
• NIH Device Record Key: 756b6f65-a122-4b80-be58-9d36c9b75656
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Multilayered Zirconia Translucent
• Version Model Number: D816A3.5MUL/T
• Company DUNS: 030580955
• Company Name: AURIDENT INC
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816795024707 [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: 4
• Public Version Date: 2019-11-04
• Device Publish Date: 2016-10-10

On-Brand Devices [Delta Multilayered Zirconia Translucent]

• 00816795024738: 98X16mm Multilayered Zirconia Translucent Shade C2
• 00816795024721: 98X16mm Multilayered Translucent Zirconia Shade B2
• 00816795024714: 98X16mm Multilayered Translucent Zirconia Shade B!
• 00816795024707: 98X16mm Multilayered Translucent Zirconia Shade A3.5
• 00816795024691: 98X16mm Multilayered Translucent Zirconia Shade A3
• 00816795024684: 98X16mm Translucent Multilayered Zirconia Shade A2