| Primary Device ID | EKUR1270075KA0 |
| NIH Device Record Key | 8b3bb103-24e5-40a5-8381-e28b1d0fa2a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Esthetic Colorant |
| Version Model Number | 127-0075KA |
| Company DUNS | 697119498 |
| Company Name | KURARAY NORITAKE DENTAL INC. |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EKUR1270075KA0 [Primary] |
| EIH | Powder, Porcelain |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-08 |
| Device Publish Date | 2022-10-31 |
| EKUR2270019KA0 | LIQUID BRUSH PEN |
| EKUR1270165KA0 | OPAQUE 12ML |
| EKUR1270155KA0 | WHITE 12ML |
| EKUR1270145KA0 | PINK 12ML |
| EKUR1270135KA0 | VIOLET 12ML |
| EKUR1270125KA0 | BLUE 12ML |
| EKUR1270115KA0 | GRAY 12ML |
| EKUR1270105KA0 | ORANGE 12ML |
| EKUR1270095KA0 | BROWN 12ML |
| EKUR1270085KA0 | D PLUS 12ML |
| EKUR1270075KA0 | C PLUS 12ML |
| EKUR1270065KA0 | B PLUS 12ML |
| EKUR1270055KA0 | A PLUS 12ML |
| EKUR1270010KA0 | BASIC KIT 144ML |