Delta Zirconia Multilayered Anterior

GUDID 00816795025032

98X18mm Multilayered Shade 3.5

AURIDENT INC

Dental porcelain/ceramic restoration kit

• Primary Device ID: 00816795025032
• NIH Device Record Key: eef20613-e04b-4bc2-bbc9-e31e94a18a15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Zirconia Multilayered Anterior
• Version Model Number: D818A3.5MUL/ANT
• 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	00816795025032 [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: 2016-10-18

On-Brand Devices [Delta Zirconia Multilayered Anterior ]

• 00816795025322: 98X18mm Multilayered Anterior Shade C2
• 00816795025315: 98X18mm Multilayered Anterior Shade B2
• 00816795025308: 98X18mm Multilayered Anterior Shade B1
• 00816795025292: 98X18mm Multilayered Anterior Shade A3.5
• 00816795025285: 98X18mm Multilayered Anterior Shade A3
• 00816795025278: 98X18mm Multilayered Anterior Shade A2
• 00816795025261: 98X18mm Multilayered Anterior Shade A1
• 00816795025063: 98X18mm Multilayered Shade C2
• 00816795025056: 98X18mm Multilayered Shade B2
• 00816795025049: 98X18mm Multilayered Shade B1
• 00816795025032: 98X18mm Multilayered Shade 3.5
• 00816795025025: 98X18mm Multilayered Shade A3
• 00816795025018: 98X18mm Multilayered Shade A2
• 00816795025001: 98X18mm Multilayered Shade A1
• 00816795024806: 98X16mm Anterior Shade C2
• 00816795024790: 98X16mm Anterior Shade B2
• 00816795024783: 98X16mm Anterior Shade B1
• 00816795024776: 98X16mm Anterior Shade 3.5
• 00816795024769: 98X16mm Anterior Shade A3
• 00816795024547: 98X14mm Anterior Shade C2
• 00816795024530: 98X14mm Anterior Shade B2
• 00816795024523: 98X14mm Anterior Shade B1
• 00816795024516: 98X14mm Anterior Shade A3.5
• 00816795024509: 98X14mm Anterior Shade A3
• 00816795024493: 98X14mm Anterior Shade A2
• 00816795024486: 98X14mm Anterior Shade A1