| Primary Device ID | EBIB037101 |
| NIH Device Record Key | da397963-a04d-4b28-b4d8-b69e6a01a126 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Provi Bond, 5 ml |
| Version Model Number | 03710 |
| Catalog Number | 03710 |
| 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 8 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBIB037101 [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 | 2018-01-18 |
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| 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 |