UltraSeal XT 3534

GUDID 00883205104175

U-Seal XT Hydro Refill OP White

ULTRADENT PRODUCTS, INC.

Dental pit/fissure sealant

• Primary Device ID: 00883205104175
• NIH Device Record Key: 96b84765-2890-40b7-9030-8ad04ef73643
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraSeal XT
• Version Model Number: 3534
• Catalog Number: 3534
• 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: 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: +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 18 Degrees Celsius and 29 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	00883205104175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112517

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [UltraSeal XT]

• 00883205104199: U-Seal XT Hydro Kit OP White
• 00883205104182: U-Seal XT Hydro Kit Natural
• 00883205104175: U-Seal XT Hydro Refill OP White
• 00883205104168: U-Seal XT Hydro Refill Natural
• 00883205104151: U-Seal XT Hydro Econo Refill OP White
• 00883205104120: UltraSeal XT plus Shade A1 Kit
• 00883205104106: UltraSeal XT plus Shade A1 Refill
• 00883205103819: UltraSeal XT Plus Opaque White Kit
• 00883205103802: UltraSeal XT Plus Opaque White Refill
• 00883205103796: UltraSeal XT Plus Opaque White Econo Refill
• 00883205103765: UltraSeal XT Plus Shade A2 Kit
• 00883205103758: UltraSeal XT Plus Shade A2 Refill
• 00883205103666: UltraSeal XT Plus Clear Refill
• 00883205103550: UltraSeal XT Plus Clear Kit
• 00883205102645: UltraSeal XT Plus Unit Dose 50pk
• 00883205101310: UltraSeal XT Hydro Unit Dose 50pk OP White
• 00883205033468: UltraSeal XT Plus Shade A2 Kit
• 00883205033437: UltraSeal XT plus Shade A1 Kit