| Primary Device ID | 03760140704516 |
| NIH Device Record Key | 30603082-0653-444a-a7b0-2429b0b3bcf5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioRoot RCS Liquid Refill Kit |
| Version Model Number | 01E0310 |
| 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 | 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 |
| Phone | 1-303-665-7535 |
| usregulatoryaffairs@septodont.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760140704516 [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 | 2019-07-11 |
| Device Publish Date | 2019-07-03 |
| 03760140703335 - BIODENTINE | 2023-06-13 Bioactive dentin substitute |
| 03760140703366 - BIODENTINE - 5 PACK | 2023-06-13 Bioactive dentin substitute |
| 03701398102709 - Ultra Safety Plus Twist kit 25G Long | 2022-10-10 100 needles 25G long (Red) and 1 handle (to be sterilized) |
| 03701398101986 - Biodentine XP 200 | 2022-02-15 Bioactive dentin substitute |
| 03701398101993 - Biodentine XP 500 | 2022-02-15 Bioactive dentin substitute |
| 03701398102556 - BioRoot Flow- 2 g | 2022-02-09 Bioactive mineral Root Canal Sealer |
| 03701398102563 - BioRoot Flow-0.5 g | 2022-02-09 Bioactive mineral Root Canal Sealer |
| 33760140704371 - Endosolv | 2021-01-14 solvent for endodontic cements |