FUSION-Zr - Dual Cure Resin Cement 06-5200

GUDID D8370652000

FUSION-Zr® Dual Cure Cement is self-adhesive. For permanent cementation of all-ceramic restorations, Zirconia, Lithium Disilicate, CAD/CAM materials, veneers, crown & bridge, inlays/onlays, PFM, posts/fiber posts.

Taub Products

Dental composite resin

• Primary Device ID: D8370652000
• NIH Device Record Key: 92b00698-6a24-4702-9307-160d7e75730c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUSION-Zr - Dual Cure Resin Cement
• Version Model Number: Crystal Clear - 7 gm Syringe
• Catalog Number: 06-5200
• 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

• Weight: 7 Gram
• Weight: 7 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat. Refrigerate. See SDS.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat. Refrigerate. See SDS.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8370652000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132393

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 - Dual Cure Resin Cement]

• D8370655510: FUSION-Zr® Dual Cure Cement is self-adhesive. For permanent cementation of all-ceramic restorat
• D8370655500: FUSION-Zr® Dual Cure Cement is self-adhesive. For permanent cementation of all-ceramic restorat
• D8370652200: FUSION-Zr® Dual Cure Cement is self-adhesive. For permanent cementation of all-ceramic restorat
• D8370652100: FUSION-Zr® Dual Cure Cement is self-adhesive. For permanent cementation of all-ceramic restorat
• D8370652000: FUSION-Zr® Dual Cure Cement is self-adhesive. For permanent cementation of all-ceramic restorat