| Primary Device ID | 03760140703366 |
| NIH Device Record Key | de74c29c-c608-41f9-8136-afd9e35dc0fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIODENTINE - 5 PACK |
| Version Model Number | 01C0605 |
| Catalog Number | 01C0605 |
| Company DUNS | 275273795 |
| Company Name | SEPTODONT SAS SPECIALITES SEPTODONT |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | 03760140703366 [Primary] |
| EJK | Liner, Cavity, Calcium Hydroxide |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-06-13 |
| Device Publish Date | 2016-09-12 |
| 03760140703359 - RACEGEL | 2025-04-03 Thermo-gelifiable gel for gingival preparation |
| 07897990328435 - SeptoWedges Refill: 100 Asst. wooden wedges | 2025-03-12 wooden wedges |
| 07897990328459 - SeptoMatrix Sectional Refill: 50 assorted matrices | 2025-03-12 Preformed sectional matrices systems for Class II restorations. |
| 07897990328466 - SeptoMatrix Sectional Refill: 50 large matrices | 2025-03-12 Preformed sectional matrices systems for Class II restorations. |
| 07897990328473 - SeptoMatrix Sectional Refill: 50 medium matrices | 2025-03-12 Preformed sectional matrices systems for Class II restorations. |
| 07897990328480 - SeptoMatrix Sectional Refill: 50 small matrices | 2025-03-12 Preformed sectional matrices systems for Class II restorations. |
| 07897990328718 - SeptoPlus Mandrel Refill: 1 mandrel snap | 2025-03-12 Mandrel for contra angle |
| 07897990328725 - SeptoDiscs Kit: 120 assorted abrasive discs+ mandrel pop-on | 2025-03-12 Finishing and polishing discs for composites |