Delta Zirconia Multilayered Translucent Disc

GUDID 00816795025452

98X12mm Multilayered Translucent Shade A2

AURIDENT INC

Dental porcelain/ceramic restoration kit

• Primary Device ID: 00816795025452
• NIH Device Record Key: 33050425-9edc-4f63-8134-0be7a8943bd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Zirconia Multilayered Translucent Disc
• Version Model Number: D812A2,MUL/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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816795025452 [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 Multilayered Translucent Disc]

• 00816795025506: 98X12mm Multilayered Translucent Shade C2
• 00816795025490: 98X12mm Multilayered Translucent Shade B2
• 00816795025483: 98X12mm Multilayered Translucent Shade B1
• 00816795025476: 98X12mm Multilayered Translucent Shade A3.5
• 00816795025469: 98x12mm Multilayered Translucent Shade A3
• 00816795025452: 98X12mm Multilayered Translucent Shade A2
• 08816795025445: 98X12mm Multilayered Translucent Shade A1
• 00816795025445: 98X12mm Multilayered Translucent Shade A1