| Primary Device ID | 88800069213124 |
| NIH Device Record Key | 8616832e-58aa-474f-9474-6687b7a6cf26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Edge .04 GP |
| Version Model Number | SGP7004-1 |
| Company DUNS | 688273010 |
| Company Name | SURE DENT CORPORATION |
| Device Count | 60 |
| DM Exempt | false |
| 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 | 08800069213128 [Primary] |
| GS1 | 88800069213124 [Unit of Use] |
| EKM | Gutta-Percha |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-22 |
| Device Publish Date | 2025-08-14 |
| 88800069209776 | EDGE 04 GUTTA PERCHA ASSORTED - (20,25,30,35,40,45) |
| 88800069209318 | Edge 04 Gutta Percha Points 50.04 |
| 88800069209301 | Edge 04 Gutta Percha Points 45.04 |
| 88800069209295 | Edge 04 Gutta Percha Points 40.04 |
| 88800069209288 | Edge 04 Gutta Percha Points 35.04 |
| 88800069209271 | Edge 04 Gutta Percha Points 30.04 |
| 88800069209264 | Edge 04 Gutta Percha Points 25.04 |
| 88800069209257 | Edge 04 Gutta Percha Points 20.04 |
| 88800069209240 | Edge 04 Gutta Percha Points 15.04 |
| 88800069213131 | Edge 04 Gutta Percha Points 80.04 |
| 88800069213124 | Edge 04 Gutta Percha Points 70.04 |
| 88800069213117 | Edge 04 Gutta Percha Points 60.04 |
| 88800069213100 | Edge 04 Gutta Percha Points 55.04 |