Delta Zirconia Anterior

GUDID 00816795024837

98X18mm Anterior Unshaded

AURIDENT INC

Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit

• Primary Device ID: 00816795024837
• NIH Device Record Key: fc8cba73-719f-47a0-baf2-ddd1ae89639b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Zirconia Anterior
• Version Model Number: D818A0ANT
• 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	00816795024837 [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: 2016-10-17

On-Brand Devices [Delta Zirconia Anterior ]

• 00816795025094: 98X18mm Anterior Unshaded
• 00816795024837: 98X18mm Anterior Unshaded
• 00816795024578: 98X16mm Anterior Zirconia White
• 00816795024318: 98X14mm Anterior Unshaded
• 00816795024189: 98X12mm Anterior White
• 00816795024073: 98X10 mm Anterior White