Delta Zirconia High Translucent Disc

GUDID 00816795025391

98X10mm High Translucent Shade B1

AURIDENT INC

Dental porcelain/ceramic restoration kit

• Primary Device ID: 00816795025391
• NIH Device Record Key: f85c208f-3e6b-4043-8a6c-d8698300993d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Zirconia High Translucent Disc
• Version Model Number: D810B1T
• 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	00816795025391 [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: 2017-03-22

On-Brand Devices [Delta Zirconia High Translucent Disc]

• 00816795025704: 98X22mm High Translucent Unshaded
• 00816795025698: 98X20mm High Translucent Shade D4
• 00816795025650: 98X20mm High Translucent Shade A4
• 00816795025636: 98X18mm High Translucent Shade D3
• 00816795025612: 98X18mm High Translucent Shade A4
• 00816795025605: 98X16mm High Translucent Shade B1
• 00816795025599: 98X14mm High Translucent Shade B1
• 00816795025582: 98X10mm High Translucent Shade D4
• 00816795025438: 98X10mm High Translucent Shade D3
• 00816795025414: 98X10mm High Translucent Shade B1
• 00816795025407: 98X10mm High Translucent Shade A4
• 00816795025391: 98X10mm High Translucent Shade B1
• 00816765025421: 98X10mm High Translucent Shade C3
• 00816495025643: 98X18mm High Translucent Shade D4
• 00816795025643: 98X18mm High Translucent Shade D4
• 00816795025421: 98X10mm High Translucent Shade C3