| Primary Device ID | E22161650 |
| NIH Device Record Key | f364438f-2d68-4d9f-9cf7-614b1686a2ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Grandio blocs |
| Version Model Number | 6165 |
| Catalog Number | 6165 |
| Company DUNS | 316699578 |
| Company Name | VOCO GmbH |
| Device Count | 5 |
| 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 | |
| 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 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 |
| 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 |
| 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 | E22161650 [Unit of Use] |
| HIBCC | E22161651 [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 | 2022-01-27 |
| Device Publish Date | 2022-01-19 |
| E22160341 | 1 each of A1 LT, B1 LT, C2 LT, BL LT, A1 HT |
| E22160331 | 1 each of A1 LT, B1 LT, C2 LT, BL LT, A1 HT |
| E22160301 | A3.5 HT (High translucent) |
| E22160291 | A3 HT (High translucent) |
| E22160281 | A2 HT (High translucent) |
| E22160271 | A1 HT (High translucent) |
| E22160241 | BL LT (Low translucent) |
| E22160231 | C2 LT (Low translucent) |
| E22160221 | B1 LT (Low translucent) |
| E22160211 | A3.5 LT (Low translucent) |
| E22160201 | A3 LT (Low translucent) |
| E22160191 | A2 LT (Low translucent) |
| E22160181 | A1 LT (Low translucent) |
| E22160151 | A3.5 HT (High translucent) |
| E22160141 | A3 HT (High translucent) |
| E22160131 | A2 HT (High translucent) |
| E22160121 | A1 HT (High translucent) |
| E22160091 | BL LT (Low Translucent) |
| E22160081 | C2 LT (Low Translucent) |
| E22160071 | B1 LT (Low Translucent) |
| E22160061 | A3.5 LT (Low Translucent) |
| E22160051 | A3 LT (Low Translucent) |
| E22160041 | A2 LT (Low Translucent) |
| E22160031 | A1 LT (Low Translucent) |
| E22160001 | Set blocks 2 × No. 12 (A2 LT, A3 HT), 3 × No. 14L (A3 LT, A3 HT, A3.5 LT), Bifix QM QuickMix s |
| E22161840 | 1x A1 LT/14L, 1xB1 LT/14L, 1xC2 LT/14L, 1xBL LT/14L, 1x A1 HT/14L |
| E22161830 | 1x A1 LT/12, 1xB1 LT/12, 1xC2 LT/12, 1xBL LT/12, 1x A1 HT/12 |
| E22161800 | 5x Gr. 14L A3.5 HT (HighTranslucent) |
| E22161790 | 5x Gr. 14L A3 HT (HighTranslucent) |
| E22161780 | 5x Gr. 14L A2 HT (HighTranslucent) |
| E22161770 | 5x Gr. 14L A1 HT (HighTranslucent) |
| E22161740 | 5x Gr. 14L BL LT (Low Translucent) |
| E221617130 | 5x Gr. 14L C2 LT (Low Translucent) |
| E221617120 | 5x Gr. 14L B1 LT (Low Translucent) |
| E22161710 | 5x Gr. 14L A3.5 LT (Low Translucent) |
| E22161700 | 5x Gr. 14L A3 LT (Low Translucent) |
| E22161690 | 5x Gr. 14L A2 LT (Low Translucent) |
| E22161680 | 5x Gr. 14L A1 LT (Low Translucent) |
| E22161650 | 5x Gr. 12 A3.5 HT (High Translucent) |
| E22161640 | 5x Gr. 12 A3 HT (High Translucent) |
| E22161630 | 5x Gr. 12 A2 HT (High Translucent) |
| E22161620 | 5x Gr. 12 A1 HT (High Translucent) |
| E22161590 | 5x Gr. 12 BL LT (Low Translucent) |
| E22161580 | 5x Gr. 12 C2 LT (Low Translucent) |
| E22161570 | 5x Gr. 12 B1 LT (Low Translucent) |
| E22161560 | 5x Gr. 12 A3.5 LT (Low Translucent) |
| E22161550 | 5x Gr. 12 A3 LT (Low Translucent) |
| E22161540 | 5x Gr. 12 A2 LT (Low Translucent) |
| E22161530 | 5x Gr. 12 A1 LT (Low Translucent) |