Emiluma 500081

GUDID 00883205015563

Emiluma Refill Kit 2 pk

ULTRADENT PRODUCTS, INC.

Silicone dental impression material

• Primary Device ID: 00883205015563
• NIH Device Record Key: ff57a7fe-3d13-48c1-8eed-e8aab67e17da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Emiluma
• Version Model Number: 500081
• Catalog Number: 500081
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00883205015563 [Primary]

FDA Product Code

• EBH: MATERIAL, IMPRESSION TRAY, RESIN

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: 2018-05-29
• Device Publish Date: 2018-04-28

On-Brand Devices [Emiluma]

• 00883205015563: Emiluma Refill Kit 2 pk
• 00883205015556: Emiluma Essentials Kit