Delta Zirconia Translucent

GUDID 00816795024127

98X10mm Translucent Shade B2

AURIDENT INC

Dental porcelain/ceramic restoration kit

• Primary Device ID: 00816795024127
• NIH Device Record Key: faae0f1a-d0db-4b44-b699-eadc491bccf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Zirconia Translucent
• Version Model Number: D810B2T
• 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	00816795024127 [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: 2016-09-19

On-Brand Devices [Delta Zirconia Translucent]

• 00816795025186: 98X18mm Translucent Shade D2
• 00816795025179: 98X18mm Translucent Shade C3
• 00816795025162: 98X18mm Translucent Shade C2
• 00816795025155: 98X18mm Translucent Shade B3
• 00816795025148: 98X18mm Translucent Shade B2
• 00816795025131: 98X18mm Translucent Shade A3.5
• 00816795025124: 98X18mm Translucent Shade A3
• 00816795025117: 98X18mm Translucent Shade A2
• 00816795025100: 98X18mm Translucent Shade A1
• 00816795025087: 98X18mm Translucent Unshaded
• 00816795024929: 98X18mm Translucent Shade D2
• 00816795024912: 98X18mm Translucent Shade C3
• 00816795024905: 98X18mm Translucent Shade C2
• 00816795024899: 98X18mm Translucent Shade B3
• 00816795024882: 98X18mm Translucent Shade B2
• 00816795024875: 98X18mm Translucent Shade 3.5
• 00816795024868: 98X18mm Translucent Shade A3
• 00816795024851: 98X18mm Translucent Shade A2
• 00816795024844: 98X18mm Shade A1
• 00816795024820: 98X18mm Translucent Unshaded
• 00816795024561: 98X16 Translucent Zirconia
• 00816795024400: 98X14mm Translucent Shade D2
• 00816795024394: 98X14mm Translucent Shade C3
• 00816795024387: 98X14mm Translucent Shade C2
• 00816795024370: 98X14mm Translucent Shade B3
• 00816795024363: 98X14mm Translucent Shade B2
• 00816795024356: 98X14mm Translucent Shade 3.5
• 00816795024349: 98X14mm Translucent Shade A3
• 00816795024332: 98X14mm Translucent Shade A2
• 00816795024325: 98X14mm Translucent Shade A1
• 00816795024301: 98X14mm Translucent Unshaded
• 00816795024295: 98X14mm High Strength Unshaded
• 00816795024288: 98X12mm Translucent Shade D2
• 00816795024271: 98X12mm Translucent Shade C3
• 00816795024264: 98X12mm Translucent Shade C2
• 00816795024257: 98X12mm Translucent Shade B3
• 00816795024240: 98X12mm Translucent Shade B2
• 00816795024233: 98X12mm Translucent Shade 3.5
• 00816795024226: 98X12mm Translucent Shade A3
• 00816795024219: 98X12mm Translucent Shade A2
• 00816795024202: 98X12mm Translucent Shade A1
• 00816795024196: 98X12mm Translucent White
• 00816795024165: 98X10mm Translucent Shade D2
• 00816795024158: 98X10mm Translucent Shade C3
• 00816795024141: 98X10mm Translucent Shade C2
• 00816795024134: 98X10mm Translucent Shade B3
• 00816795024127: 98X10mm Translucent Shade B2
• 00816795024110: 98X10mm Translucent Shade 3.5
• 00816795024103: 98X10mm Translucent Shade A3
• 00816795024097: 98X10mm Translucent Shade A2