UltraCal XS 5145

GUDID 00883205033253

UltraCal XS Refill

ULTRADENT PRODUCTS, INC.

Calcium hydroxide dental suspension

• Primary Device ID: 00883205033253
• NIH Device Record Key: 3f6ceefa-5d67-4c43-becc-3fe84719d8ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraCal XS
• Version Model Number: 5145
• Catalog Number: 5145
• 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: 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
• 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
• 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	00883205033253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211905

FDA Product Code

• KIF: Resin, Root Canal Filling

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: 2023-06-26
• Device Publish Date: 2023-06-17

On-Brand Devices [UltraCal XS]

• 00883205103987: UltraCal XS Mini Kit
• 00883205103970: UltraCal XS Kit
• 00883205103741: UltraCal XS Refill
• 00883205102515: UltraCal XS Econo Refill
• 00883205033260: UltraCal XS Econo Refill
• 00883205033253: UltraCal XS Refill
• 00883205033246: UltraCal XS Kit