FUSION Silane 06-2011

GUDID D8370620110

A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic restorations, and recommended for best adhesion to veneers, crowns and other ceramic restorations. Also use it for easy chair-side repairs to: porcelain-gold restorations, porcelain jackets, porcelain denture teeth, popped-out porcelain veneers or facings. Eliminates costly laboratory remakes. This non-toxic, non-irritating formula can be used in or out of the mouth.

Taub Products

Dental repair kit, ceramic

• Primary Device ID: D8370620110
• NIH Device Record Key: 081a3ea2-9fd3-4f95-9c29-7dceb1bf107b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUSION Silane
• Version Model Number: B - 6 oz
• Catalog Number: 06-2011
• Company DUNS: 067488114
• Company Name: Taub Products
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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: 6 Fluid Ounce
• Total Volume: 6 Fluid Ounce

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8370620110 [Primary]

FDA Product Code

• EBO: Denture Repair Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-26

On-Brand Devices [FUSION Silane]

• D8370620200: Mixing bottle for FUSION Silane. A two-part silane system creating a stronger chemical bond to f
• D8370620110: A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic
• D8370620100: A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic
• D8370620010: A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic
• D8370620000: A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic
• D8370610020: A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic
• D8370610000: A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic