Delta Zirconia High Strength

GUDID 00816795024554

98X16mm High Strength Unshaded

AURIDENT INC

Dental porcelain/ceramic restoration kit

• Primary Device ID: 00816795024554
• NIH Device Record Key: 06310af2-7382-456a-8b63-b1f81f2c71a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Zirconia High Strength
• Version Model Number: D816A0G
• 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	00816795024554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141727

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: 2016-10-12

On-Brand Devices [Delta Zirconia High Strength]

• 00816795025070: 98X18mm High Strength Unshaded
• 00816795024813: 98X18mm Unshaded
• 00816795024554: 98X16mm High Strength Unshaded