OptiBond All-In-One 33535

GUDID 10841396107242

One Component, Self-Etching Dental Adhesive; Unidose; Sample - Not For Sale

Kerr Corporation

Dentine bonding agent/set

• Primary Device ID: 10841396107242
• NIH Device Record Key: cf5e8b15-9e38-4fde-b6ea-bb4f90e9cb49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiBond All-In-One
• Version Model Number: 33535
• Catalog Number: 33535
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• Device Count: 3
• 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: 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: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com

Device Dimensions

• Total Volume: 0.54 Milliliter
• Total Volume: 0.54 Milliliter
• Total Volume: 0.54 Milliliter
• Total Volume: 0.54 Milliliter
• Total Volume: 0.54 Milliliter
• Total Volume: 0.54 Milliliter
• Total Volume: 0.54 Milliliter
• Total Volume: 0.54 Milliliter
• Total Volume: 0.54 Milliliter
• Total Volume: 0.54 Milliliter
• Total Volume: 0.54 Milliliter
• Total Volume: 0.54 Milliliter
• Total Volume: 0.54 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841396107245 [Unit of Use]
GS1	10841396107242 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-02-16
• Device Publish Date: 2016-08-01

On-Brand Devices [OptiBond All-In-One]

• 00841396108105: Single-Component, Self-Etch Dental Adhesive; Bottle Kit
• H290335332: Single-Component, Self-Etch Dental Adhesive; 100-Pack Unidose Kit
• 10841396107242: One Component, Self-Etching Dental Adhesive; Unidose; Sample - Not For Sale