Ultra-Blend Plus 1016

GUDID 00883205104038

Ultra-Blend Plus Mini Kit Universal

ULTRADENT PRODUCTS, INC.

Calcium hydroxide dental cement

• Primary Device ID: 00883205104038
• NIH Device Record Key: 164fc01c-5aaf-41c5-8534-4d79b0f713c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra-Blend Plus
• Version Model Number: 1016
• Catalog Number: 1016
• 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	00883205104038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970113

FDA Product Code

• EJK: LINER, CAVITY, CALCIUM HYDROXIDE

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 [Ultra-Blend Plus]

• 00883205104038: Ultra-Blend Plus Mini Kit Universal
• 00883205103611: Ultra-Blend Plus Kit
• 00883205103604: Ultra-Blend Plus Dentin Refill
• 00883205103598: Ultra-Blend Plus Opaque White Refill