Delta Zirconia Translucent Shaded

GUDID 00816795024615

98X16mm Translucent Zirconia Shaded A3.5

AURIDENT INC

Dental porcelain/ceramic restoration kit

• Primary Device ID: 00816795024615
• NIH Device Record Key: 3f38b4d4-5e5b-4dd4-a2a5-eb07242e4868
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Zirconia Translucent Shaded
• Version Model Number: D816A3.5T
• 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	00816795024615 [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 Zirconia Translucent Shaded]

• 00816795024660: 98X16mm Translucent Zirconia Shade D2
• 00816795024653: 98X16mm Translucent Zirconia Shade C#
• 00816795024646: 98X16mm Translucent Zirconia Shade C2
• 00816795024639: 98X16mm Translucent Zirconia Shade B#
• 00816795024622: 98X16mm Translucent Zirconia Shade B2
• 00816795024615: 98X16mm Translucent Zirconia Shaded A3.5
• 00816795024608: 98X16mm Translucent Zirconia Shaded A3
• 00816795024592: 98X16mm Translucent Zirconia Shade A2
• 00816795024585: 98X16mm Zirconia Translucent Shade A1