EndoREZ 5904

GUDID 00883205107817

EndoREZ Mini Obturation Kit

ULTRADENT PRODUCTS, INC.

Endodontic filling/sealing material

• Primary Device ID: 00883205107817
• NIH Device Record Key: 29556bb0-ed7d-4a11-bea9-513b2b633993
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoREZ
• Version Model Number: 5904
• Catalog Number: 5904
• 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	00883205107817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992380

FDA Product Code

• EFB: HANDPIECE, AIR-POWERED, 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: 2018-09-03
• Device Publish Date: 2016-09-22

On-Brand Devices [EndoREZ]

• 00883205107930: EndoREZ Accelerator 20 vial kit
• 00883205107848: EndoREZ Obturation Kit, 0.06 Taper
• 00883205107831: EndoREZ Obturation Kit, 0.04 Taper
• 00883205107824: EndoREZ Obturation Kit 0.02 Taper
• 00883205107817: EndoREZ Mini Obturation Kit
• 00883205106803: EndoREZ Refill Kit
• 00883205102768: Sample EndoREZ Obturation System