| Primary Device ID | 88800069213179 |
| NIH Device Record Key | f0379b58-8deb-4763-bf97-6a9b7544f967 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Edge .04 PP |
| Version Model Number | SPP8004-1 |
| Company DUNS | 688273010 |
| Company Name | SURE DENT CORPORATION |
| Device Count | 100 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800069213173 [Primary] |
| GS1 | 88800069213179 [Unit of Use] |
| EKN | Point, Paper, 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 | 2025-08-22 |
| Device Publish Date | 2025-08-14 |
| 88800069209813 | EDGE X7 04 PAPER POINTS ASSORTED - (20,25,30,35,40,45) |
| 88800069209561 | Edge 04 Paper Points 50.04 |
| 88800069209554 | Edge 04 Paper Points 45.04 |
| 88800069209547 | Edge 04 Paper Points 40.04 |
| 88800069209530 | Edge 04 Paper Points 35.04 |
| 88800069209523 | Edge 04 Paper Points 30.04 |
| 88800069209516 | Edge 04 Paper Points 25.04 |
| 88800069209509 | Edge 04 Paper Points 20.04 |
| 88800069209493 | Edge 04 Paper Points 15.04 |
| 88800069213179 | Edge 04 Paper Points 80.04 |
| 88800069213162 | Edge 04 Paper Points 70.04 |
| 88800069213155 | Edge 04 Paper Points 60.04 |
| 88800069213148 | Edge 04 Paper Points 55.04 |