UltraTemp 5916

GUDID 00883205106858

UltraTemp Regular Kit

ULTRADENT PRODUCTS, INC.

Zinc polycarboxylate dental cement

• Primary Device ID: 00883205106858
• NIH Device Record Key: a0d6e31c-18cd-45e6-89ed-32c0cbbe9b77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraTemp
• Version Model Number: 5916
• Catalog Number: 5916
• 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 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205106858 [Primary]

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: 2
• Public Version Date: 2018-03-29
• 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