| Primary Device ID | 03701398102556 |
| NIH Device Record Key | 7207288b-3089-4cb1-92f9-47c32121f975 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioRoot Flow- 2 g |
| Version Model Number | 01E0510 |
| Catalog Number | 01E0510 |
| 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 |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com | |
| Phone | 1-800-872-8305 |
| salesorders@septodont.com |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Moisture |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701398102556 [Primary] |
| KIF | Resin, Root Canal Filling |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-09 |
| Device Publish Date | 2022-02-01 |
| 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 |
| 07897990328732 - SeptoDiscs Refill:1/2” 50 assorted abrasive discs | 2025-03-12 Finishing and polishing discs for composites |