Delta Zirconia High Translucent

GUDID 00816795025681

98X20mm High Translucent Shade D3

AURIDENT INC

Dental porcelain/ceramic restoration kit

• Primary Device ID: 00816795025681
• NIH Device Record Key: 766f1b90-4e5d-49b7-b5e1-25884fbb0b10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Zirconia High Translucent
• Version Model Number: D820D3T
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816795025681 [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: 2017-03-23

On-Brand Devices [Delta Zirconia High Translucent]

• 00816795025728: 98X25mm High Translucent Unshaded
• 00816795025681: 98X20mm High Translucent Shade D3
• 00816795025674: 98X20mm High Translucent Shade C1
• 00816795025667: 98X20mm High Translucent Shade B1
• 00816795025629: 98X18mm High Translucent Shade B1