Opal Band 500000

GUDID 00883205107268

Opal Band Cement Kit

ULTRADENT PRODUCTS, INC.

Orthodontic bracket adhesive

• Primary Device ID: 00883205107268
• NIH Device Record Key: 219a7fb3-45fb-4c3a-be09-b10a09f02135
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opal Band
• Version Model Number: 500000
• Catalog Number: 500000
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, 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: true
• 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: +1(801)572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205107268 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111696

FDA Product Code

• DYH: ADHESIVE, BRACKET AND TOOTH CONDITIONER, 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: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Opal Band]

• 00883205107367: Opal Band Cement Trial Syringe
• 00883205107268: Opal Band Cement Kit
• 00883205015600: Opal Band Mixing Tips 50 Pack