EdgeTaper Encore™ 8806387821748_4

GUDID 20818365021578

Classic Fit EdgeTaper Encore™ Paper Points X3

US ENDODONTICS, LLC

Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point

• Primary Device ID: 20818365021578
• NIH Device Record Key: b60d7754-f5df-479e-98bd-c7aa1d5b09a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeTaper Encore™
• Version Model Number: 8806387821748_4
• Catalog Number: 8806387821748_4
• 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: true
• 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	10818365021571 [Primary]
GS1	20818365021578 [Unit of Use]

FDA Product Code

• EKN: POINT, PAPER, ENDODONTIC

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 Encore™]

• 20818365021592: Classic Fit EdgeTaper Encore™ Paper Points X5
• 20818365021585: Classic Fit EdgeTaper Encore™ Paper Points X4
• 20818365021578: Classic Fit EdgeTaper Encore™ Paper Points X3
• 20818365021561: Classic Fit EdgeTaper Encore™ Paper Points X2
• 20818365021554: Classic Fit EdgeTaper Encore™ Paper Points X1
• 20818365021547: Classic Fit EdgeTaper Encore™ Gutta Percha Points™ X5
• 20818365021530: Classic Fit EdgeTaper Encore™ Gutta Percha Points™ X4
• 20818365021523: Classic Fit EdgeTaper Encore™ Gutta Percha Points™ X3
• 20818365021516: Classic Fit EdgeTaper Encore™ Gutta Percha Points™ X2
• 20818365021509: Classic Fit EdgeTaper Encore™ Gutta Percha Points™ X1
• 10818365027962: Slim Fit EdgeTaper Encore™ Paper Points X5
• 10818365027955: Slim Fit EdgeTaper Encore™ Paper Points X4
• 10818365027948: Slim Fit EdgeTaper Encore™ Paper Points X3
• 10818365027931: Slim Fit EdgeTaper Encore™ Paper Points X2
• 10818365027924: Slim Fit EdgeTaper Encore™ Paper Points X1
• 10818365027917: Slim Fit EdgeTaper Encore™ Gutta Percha Points™ X5
• 10818365027900: Slim Fit EdgeTaper Encore™ Gutta Percha Points™ X4
• 10818365027894: Slim Fit EdgeTaper Encore™ Gutta Percha Points™ X3
• 10818365027887: Slim Fit EdgeTaper Encore™ Gutta Percha Points™ X2
• 10818365027870: Slim Fit EdgeTaper Encore™ Gutta Percha Points™ X1
• 10818365020703: MIS EdgeTaper Encore™ Paper Points X3
• 10818365020697: MIS EdgeTaper Encore™ Paper Points X2
• 10818365020680: MIS EdgeTaper Encore™ Paper Points X1
• 10818365020673: MIS EdgeTaper Encore™ Gutta Percha Points™ X3
• 10818365020666: MIS EdgeTaper Encore™ Gutta Percha Points™ X2
• 10818365020659: MIS EdgeTaper Encore™ Gutta Percha Points™ X1