UltraTemp 6040

GUDID 00883205106865

UltraTemp Rez Regular Set Kit

ULTRADENT PRODUCTS, INC.

Zinc polycarboxylate dental cement

• Primary Device ID: 00883205106865
• NIH Device Record Key: b3bf1b0d-5ee9-440b-b43f-14946703f348
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraTemp
• Version Model Number: 6040
• Catalog Number: 6040
• 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	00883205106865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080768

FDA Product Code

• EMA: CEMENT, DENTAL

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 [UltraTemp]

• 00883205107398: Sample UltraTemp Rez Fast Set
• 00883205107381: Sample UltraTemp Regular Set
• 00883205106872: UltraTemp Rez Fast Set Kit
• 00883205106865: UltraTemp Rez Regular Set Kit
• 00883205106858: UltraTemp Regular Kit