EDGETAPER BLAZE UTOPIA ETBUA31SU

GUDID 10818365029201

Sterile Endodontic Rotary File

US ENDODONTICS, LLC

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: 10818365029201
• NIH Device Record Key: 7b1a9e09-3bda-4d46-8f72-a35b02b37ec7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDGETAPER BLAZE UTOPIA
• Version Model Number: ETBUA31SU
• Catalog Number: ETBUA31SU
• Company DUNS: 061317427
• Company Name: US ENDODONTICS, LLC
• Device Count: 6
• 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	00818365029204 [Primary]
GS1	10818365029201 [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 [EDGETAPER BLAZE UTOPIA]

• 10818365029201: Sterile Endodontic Rotary File
• 10818365029195: Sterile Endodontic Rotary File
• 10818365029188: Sterile Endodontic Rotary File
• 10818365029171: Sterile Endodontic Rotary File
• 10818365029164: Sterile Endodontic Rotary File
• 10818365029157: Sterile Endodontic Rotary File
• 10818365029140: Sterile Endodontic Rotary File
• 10818365029133: Sterile Endodontic Rotary File
• 10818365029126: Sterile Endodontic Rotary File
• 10818365029119: Sterile Endodontic Rotary File
• 10818365029102: Sterile Endodontic Rotary File
• 10818365029096: Sterile Endodontic Rotary File
• 10818365029089: Sterile Endodontic Rotary File
• 10818365029072: Sterile Endodontic Rotary File
• 10818365029065: Sterile Endodontic Rotary File
• 10818365029058: Sterile Endodontic Rotary File
• 10818365029041: Sterile Endodontic Rotary File
• 10818365029034: Sterile Endodontic Rotary File
• 10818365029027: Sterile Endodontic Rotary File