| Primary Device ID | EBIB037301 |
| NIH Device Record Key | 18e7a981-a865-4f6a-9fcd-ab43dd747335 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BISICO Cementime DC |
| Version Model Number | 03730 |
| Catalog Number | 03730 |
| 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 | 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 | +495218016800 |
| info@bisico.de |
| Handling Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBIB037301 [Primary] |
| EMA | Cement, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-06-29 |
| Device Publish Date | 2017-11-29 |
| 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 |