| Primary Device ID | EBIB738101 |
| NIH Device Record Key | c1515999-8c31-46c4-a679-8cf479ec3eb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BISICO Softbase |
| Version Model Number | 73810 |
| Catalog Number | 73810 |
| Company DUNS | 316133664 |
| Company Name | bisico Bielefelder Dentalsilicone GmbH & Co. KG |
| 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +495218016800 |
| info@bisico.de |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBIB738101 [Primary] |
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-06-29 |
| Device Publish Date | 2020-06-18 |
| EBIB001101 - BISICO Plast | 2023-07-06 condensation-curing dental impression silicone |
| EBIB012001 - BISICO S3 Heavy 2x170ml | 2023-07-06 Addition-curing dental impression silicone |
| EBIB019101 - BISICO Dispenser 50 | 2023-07-06 A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into |
| EBIB019201 - BISICO Dispenser 75 | 2023-07-06 A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into |
| EBIB019401 - BISICO Dispenser 25 | 2023-07-06 A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into |
| EBIB020201 - BISICO Dispenser 4:1 | 2023-07-06 A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into |
| EBIB712301 - BISICO S3 i Heavy 4x75ml | 2023-07-06 Addition-curing dental impression silicone |
| EBIB723211 - BISICO S4 suhy - impressa sure light | 2023-07-06 Addition-curing dental impression silicone |