| Primary Device ID | 07640142446507 |
| NIH Device Record Key | a89820dd-e47a-4bca-91c0-d4373490d3c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EdgeDiamond Utopia |
| Version Model Number | EDUASST21V |
| Catalog Number | EDUASST21V |
| Company DUNS | 482884061 |
| Company Name | FKG Dentaire Sàrl |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640142446293 [Primary] |
| GS1 | 07640142446507 [Unit of Use] |
| GS1 | 07640142446712 [Primary] |
| EKS | File, Pulp Canal, Endodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-26 |
| Device Publish Date | 2024-11-18 |
| 07640142446521 | EdgeDiamond Utopia Assortment, 31 mm |
| 07640142446514 | EdgeDiamond Utopia Assortment, 25 mm |
| 07640142446507 | EdgeDiamond Utopia Assortment, 21 mm |
| 07640142446705 | EdgeDiamond Utopia - FXL, no 50, 07v, 31 mm |
| 07640142446699 | EdgeDiamond Utopia - FXL, no 50, 07v, 25 mm |
| 07640142446682 | EdgeDiamond Utopia - FXL, no 50, 07v, 21 mm |
| 07640142446675 | EdgeDiamond Utopia - FX, no 35, 07v, 31 mm |
| 07640142446668 | EdgeDiamond Utopia - FX, no 35, 07v, 25 mm |
| 07640142446651 | EdgeDiamond Utopia - FX, no 35, 07v, 21 mm |
| 07640142446644 | EdgeDiamond Utopia - F3, no 30, 07v, 31 mm |
| 07640142446637 | EdgeDiamond Utopia - F3, no 30, 07v, 25 mm |
| 07640142446620 | EdgeDiamond Utopia - F3, no 30, 07v, 21 mm |
| 07640142446613 | EdgeDiamond Utopia - F2, no 25, 07v, 31 mm |
| 07640142446606 | EdgeDiamond Utopia - F2, no 25, 07v, 25 mm |
| 07640142446590 | EdgeDiamond Utopia - F2, no 25, 07v, 21 mm |
| 07640142446583 | EdgeDiamond Utopia - F1, no 20, 07v, 31 mm |
| 07640142446576 | EdgeDiamond Utopia - F1, no 20, 07v, 25 mm |
| 07640142446569 | EdgeDiamond Utopia - F1, no 20, 07v, 21 mm |
| 07640142446552 | EdgeDiamond Utopia - Shaper, no 20, 04v, 31 mm |
| 07640142446538 | EdgeDiamond Utopia - Shaper, no 20, 04v, 25 mm |