| 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 |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10818365021571 [Primary] |
| GS1 | 20818365021578 [Unit of Use] |
| EKN | POINT, PAPER, ENDODONTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-03 |
| Device Publish Date | 2023-06-25 |
| 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 |