| Primary Device ID | EKUR004221KA1 |
| NIH Device Record Key | 0e345f71-0de6-4aa5-868f-6ea05360ed3f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PANAVIA SA Cement Universal |
| Version Model Number | #4221-KA |
| Company DUNS | 697119498 |
| Company Name | KURARAY NORITAKE DENTAL INC. |
| Device Count | 20 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EKUR004221KA0 [Unit of Use] |
| HIBCC | EKUR004221KA1 [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 | 2019-07-01 |
| Device Publish Date | 2019-06-21 |
| EKUR004221KA1 | Automix Endo tip (SS) |
| EKUR004218KA1 | Automix Mixing tip |
| EKUR004217KA1 | Automix Trial (Translucent) |
| EKUR004216KA1 | Automix Trial (Universal (A2)) |
| EKUR004214KA1 | Automix (Translucent) |
| EKUR004213KA1 | Automix (White) |
| EKUR004212KA1 | Automix (Universal (A2)) |
| EKUR004211KA1 | Automix Value Pack (Translucent) |
| EKUR004210KA1 | Automix Value Pack (Universal (A2)) |
| EKUR004204KA1 | Handmix (Translucent) |
| EKUR004203KA1 | Handmix (White) |
| EKUR004202KA1 | Handmix (Universal (A2)) |