EDGEONE BLAZE UTOPIA EOBU3521SU

GUDID 10818365029287

Sterile Endodontic Rotary File

US ENDODONTICS, LLC

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: 10818365029287
• NIH Device Record Key: 455b2578-7139-4771-98ca-a7ab15e03e18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDGEONE BLAZE UTOPIA
• Version Model Number: EOBU3521SU
• Catalog Number: EOBU3521SU
• Company DUNS: 061317427
• Company Name: US ENDODONTICS, LLC
• Device Count: 3
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818365029280 [Primary]
GS1	10818365029287 [Unit of Use]

FDA Product Code

• EKS: FILE, PULP CANAL, ENDODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-13
• Device Publish Date: 2023-07-05

On-Brand Devices [EDGEONE BLAZE UTOPIA]

• 10818365029409: Sterile Endodontic Rotary File
• 10818365029393: Sterile Endodontic Rotary File
• 10818365029386: Sterile Endodontic Rotary File
• 10818365029362: Sterile Endodontic Rotary File
• 10818365029355: Sterile Endodontic Rotary File
• 10818365029348: Sterile Endodontic Rotary File
• 10818365029331: Sterile Endodontic Rotary File
• 10818365029324: Sterile Endodontic Rotary File
• 10818365029317: Sterile Endodontic Rotary File
• 10818365029300: Sterile Endodontic Rotary File
• 10818365029294: Sterile Endodontic Rotary File
• 10818365029287: Sterile Endodontic Rotary File
• 10818365029270: Sterile Endodontic Rotary File
• 10818365029263: Sterile Endodontic Rotary File
• 10818365029256: Sterile Endodontic Rotary File
• 10818365029249: Sterile Endodontic Rotary File
• 10818365029232: Sterile Endodontic Rotary File
• 10818365029225: Sterile Endodontic Rotary File