EdgeTaper Encore™ METEX2GP

GUDID 10818365020666

MIS EdgeTaper Encore™ Gutta Percha Points™ X2

US ENDODONTICS, LLC

Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha

• Primary Device ID: 10818365020666
• NIH Device Record Key: 3ce536f7-fe54-4863-b9a8-9decd294ec70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeTaper Encore™
• Version Model Number: METEX2GP
• Catalog Number: METEX2GP
• 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	00818365020669 [Primary]
GS1	10818365020666 [Unit of Use]

FDA Product Code

• EKM: GUTTA-PERCHA

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