EdgeTaper Platinum™ ETF3BCGP

GUDID 10818365020734

EdgeTaper Platinum™ Bioceramic Gutta Percha Points F3

US ENDODONTICS, LLC

Calcium hydroxide dental cement

• Primary Device ID: 10818365020734
• NIH Device Record Key: 444b4ac6-38c5-43a6-8b75-b6e8702f9891
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeTaper Platinum™
• Version Model Number: ETF3BCGP
• Catalog Number: ETF3BCGP
• Company DUNS: 061317427
• Company Name: US ENDODONTICS, LLC
• Device Count: 60
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818365020737 [Primary]
GS1	10818365020734 [Unit of Use]

FDA Product Code

• KIF: RESIN, ROOT CANAL FILLING

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: 2023-07-03
• Device Publish Date: 2023-06-25

On-Brand Devices [EdgeTaper Platinum™]

• 10818365020758: EdgeTaper Platinum™ Bioceramic Gutta Percha Points F5
• 10818365020741: EdgeTaper Platinum™ Bioceramic Gutta Percha Points F4
• 10818365020734: EdgeTaper Platinum™ Bioceramic Gutta Percha Points F3
• 10818365020727: EdgeTaper Platinum™ Bioceramic Gutta Percha Points F2
• 10818365020710: EdgeTaper Platinum™ Bioceramic Gutta Percha Points F1
• 10818365020574: MIS EdgeTaper Paper Points F5
• 10818365020567: MIS EdgeTaper Paper Points F4
• 10818365020550: MIS EdgeTaper Paper Points F3
• 10818365020543: MIS EdgeTaper Paper Points F2
• 10818365020536: MIS EdgeTaper Paper Points F1
• 10818365020529: MIS EdgeTaper Gutta Percha Points F5
• 10818365020512: MIS EdgeTaper Gutta Percha Points F4
• 10818365020505: MIS EdgeTaper Gutta Percha Points F3
• 10818365020499: MIS EdgeTaper Gutta Percha Points F2
• 10818365020482: MIS EdgeTaper Gutta Percha Points F1