| Primary Device ID | E22115191 |
| NIH Device Record Key | 778767e9-10ee-4f3f-b042-cbcd518202eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Futurabond M+ |
| Version Model Number | 1519 |
| Catalog Number | 1519 |
| Company DUNS | 316699578 |
| Company Name | VOCO GmbH |
| 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 | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E22115191 [Primary] |
| KLE | Agent, Tooth Bonding, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-22 |
| Device Publish Date | 2024-08-14 |
| E22115181 | Light-curing self-etch-bond reinforced with nano-fillers. Chemical-curing in areas inaccessible |
| E22115161 | Light-curing self-etch-bond reinforced with nano-fillers. Chemical-curing in areas inaccessible |
| E22115151 | Light-curing self-etch-bond reinforced with nano-fillers. Chemical-curing in areas inaccessible |
| E22115191 | Light-curing self-etch-bond reinforced with nano-fillers. Chemical-curing in areas inaccessible |