FUSION-Zr - Veneer Cement 06-5115

GUDID D8370651150

FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.

Taub Products

Dental composite resin

• Primary Device ID: D8370651150
• NIH Device Record Key: 95460716-1f77-496e-bad8-473915ba2ba6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUSION-Zr - Veneer Cement
• Version Model Number: Opal White - 3ml Syringe
• Catalog Number: 06-5115
• Company DUNS: 067488114
• Company Name: Taub Products
• 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

Customer Support Contacts

• Phone: +1.201.798.5353
• Email: customerservice@taubdental.com
• Phone: +1.201.798.5353
• Email: customerservice@taubdental.com

Device Dimensions

• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat. Store at room temperature. See SDS.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat. Store at room temperature. See SDS.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8370651150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073101

FDA Product Code

• EMA: Cement, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-05

On-Brand Devices [FUSION-Zr - Veneer Cement]

• D8370655200: FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive ceme
• D8370655100: FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive ceme
• D8370655000: FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive ceme
• D8370651150: FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive ceme
• D8370651050: FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive ceme
• D8370650300: FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive ceme
• D8370650200: FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive ceme
• D8370650100: FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive ceme
• D8370650000: FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive ceme