| Primary Device ID | E22162701 |
| NIH Device Record Key | 2bbd3276-67e2-4bc8-ba17-d540146b3942 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GrandioSO Unlimited |
| Version Model Number | 6270 |
| Catalog Number | 6270 |
| 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 | 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 | 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 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E22162701 [Primary] |
| EBF | Material, Tooth Shade, 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 | 2025-09-08 |
| Device Publish Date | 2025-08-29 |
| E22162771 | light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.3g, BL |
| E22162761 | light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.3g, opaque |
| E22162701 | light-curing, radiopaque nano-hybrid universal composite, Set Caps 75x0.3g |