Gleo 5830

GUDID 00883205043115

Gleo Varnish 10ml Tube Kit Bubblegum

ULTRADENT PRODUCTS, INC.

Dental coating, tooth-desensitizing, professional

• Primary Device ID: 00883205043115
• NIH Device Record Key: 756c05e5-88b8-4701-9726-5db56bd35cc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gleo
• Version Model Number: 5830
• Catalog Number: 5830
• 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: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205043115 [Primary]

FDA Product Code

• LBH: Varnish, Cavity

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: 2025-06-11
• Device Publish Date: 2025-06-03

On-Brand Devices [Gleo]

• 00883205043115: Gleo Varnish 10ml Tube Kit Bubblegum
• 00883205042361: Gleo Varnish 10ml Tube Kit Berry