Ultra-Bond® 032491110

GUDID D8130324911100

BLOCK OUT UBP A1 KIT

DEN-MAT HOLDINGS, LLC

Dental composite resin

• Primary Device ID: D8130324911100
• NIH Device Record Key: 4bb1358f-48bf-4051-91a7-c5bb2abc8cbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra-Bond®
• Version Model Number: 032491110
• Catalog Number: 032491110
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• 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: false
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Bring to room temperature prior to use
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Temperature: Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8130324911100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K881918

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: 2016-09-24

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