Delta Zirconia Multilayered Translucent

GUDID 00816795025216

98X18mm Multilayered Translucent Shade A3

AURIDENT INC

Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit

• Primary Device ID: 00816795025216
• NIH Device Record Key: b2184d16-b606-49d9-a76d-64c46fc1789a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Zirconia Multilayered Translucent
• Version Model Number: D820A3MUL/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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816795025216 [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: 2016-10-20

On-Brand Devices [Delta Zirconia Multilayered Translucent ]

• 00816795025254: 98X18mm Multilayered Translucent Shade C2
• 00816795025247: 98X18mm Multilayered Translucent Shade B2
• 00816795025230: 98X18mm Multilayered Translucent Shade B1
• 00816795025223: 98X18mm Multilayered Translucent Shade A3.5
• 00816795025216: 98X18mm Multilayered Translucent Shade A3
• 00816795025209: 98X18mm Translucent Shade A2
• 00816795025193: 98X18mm Translucent Shade A1
• 00816795024998: 98X18mm Translucent Shade C2
• 00816795024981: 98X18mm Translucent Shade B2
• 00816795024974: 98X18mm Translucent Shade B1
• 00816795024967: 98X18mm Translucent Shade A3.5
• 00816795024950: 98X18mm Translucent Shade A3
• 00816795024943: 98X18mm Translucent Shade A2
• 00816795024936: 98X18mm Translucent Shade A1
• 00816795024479: 98X14mm Translucent Shade C2
• 00816795024462: 98X14mm Translucent Shade B2
• 00816795024455: 98X14mm Translucent Shade B1
• 00816795024448: 98X14mm Translucent Shade 3.5
• 00816795024431: 98X14mm Translucent Shade A3
• 00816795024424: 98X14mm Translucent Shade A2
• 00816795024417: 98X14mm Translucent Shade A1