Brush&Bond® S220

GUDID 00810000529667

Brush&Bond® MAX Kit

PARKELL, INC.

Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set

• Primary Device ID: 00810000529667
• NIH Device Record Key: d9c86e56-45ae-4d6c-9021-06e1c16a4497
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brush&Bond®
• Version Model Number: S220
• Catalog Number: S220
• Company DUNS: 009900424
• Company Name: PARKELL, 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: 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

Customer Support Contacts

• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment. Refrigeration prolongs shelf-life, but avoid freezing. Bring product to room temperature before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store this product tightly sealed in a cool, dark, low-humidity environment at room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000529667 [Primary]

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-02
• Device Publish Date: 2022-04-22

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• 00810000529124: Brush&Bond® Dentin/Enamel Bonding Liquid 3ml.
• 00810000529117: Brush&Bond® Kit
• 00810000529094: Brush&Bond® Universal Liquid 3ml.
• 00810000529087: Brush&Bond® Universal Bonding System
• M595S2880: Brush&Bond® Kit with Mini/Endo B&B Activator Brushes
• M595S2871: Brush&Bond® Mini/Endo Activator Brushes (Pkg. of 100 pcs.)
• M595S2861: Brush&Bond® Standard Activator Brushes (Pkg. of 100 pcs.)
• M595S2850: Brush&Bond® Dentin/Enamel Bonding Liquid 3ml.
• M595S2840: Brush&Bond® Kit
• M595S2420: Brush&Bond® Universal Liquid 3ml.
• M595S2400: Brush&Bond® Universal Bonding System
• 00810000529674: Brush&Bond® MAX Bonding Liner
• 00810000529667: Brush&Bond® MAX Kit
• 10810000529145: Brush&Bond® Mini/Endo Activator Brushes (Pkg. of 100 pcs.)
• 10810000529138: Brush&Bond® Standard Activator Brushes (Pkg. of 100 pcs.)