UltraSeal XT Hydro 5546

GUDID 00883205035240

UltraSeal XT Hydro Econo Refill A2 Opaque - Bioprotection by Nobio

ULTRADENT PRODUCTS, INC.

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• Primary Device ID: 00883205035240
• NIH Device Record Key: 7ecde0a8-50a4-46f9-bf6d-543e75bf2a9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraSeal XT Hydro
• Version Model Number: 5546
• Catalog Number: 5546
• 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
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(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
• 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	00883205035240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232498

FDA Product Code

• EBC: SEALANT, PIT AND FISSURE, AND CONDITIONER

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: 2023-09-11
• Device Publish Date: 2023-09-01

On-Brand Devices [UltraSeal XT Hydro]

• 00883205035257: Sample UltraSeal XT Hydro - Bioprotection by Nobio
• 00883205035240: UltraSeal XT Hydro Econo Refill A2 Opaque - Bioprotection by Nobio
• 00883205035226: UltraSeal XT Hydro Refill A2 Opaque - Bioprotection by Nobio
• 00883205035202: UltraSeal XT Hydro Kit A2 Opaque Bioprotection by Nobio