| Primary Device ID | EKUR001024KA1 |
| NIH Device Record Key | 1ced5dff-d361-485f-a14d-b8a03dca0fd8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Applicator brush (fine) |
| Version Model Number | #1024-KA |
| Company DUNS | 697119498 |
| Company Name | KURARAY NORITAKE DENTAL INC. |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EKUR001024KA0 [Unit of Use] |
| HIBCC | EKUR001024KA1 [Primary] |
| KXR | Applicator, 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 | 2024-09-03 |
| Device Publish Date | 2024-08-26 |
| EKUR1259852KA0 - KATANA™ Zirconia | 2026-03-09 YML T14 EW0 C |
| EKUR1259863KA0 - KATANA™ Zirconia | 2026-03-09 YML T18 EW0 C |
| EKUR1259874KA0 - KATANA™ Zirconia | 2026-03-09 YML T22 EW0 C |
| EKUR1259882KA0 - KATANA™ Zirconia | 2026-03-09 YML T14 EW C |
| EKUR1259893KA0 - KATANA™ Zirconia | 2026-03-09 YML T18 EW C |
| EKUR1259904KA0 - KATANA™ Zirconia | 2026-03-09 YML T22 EW C |
| EKUR1259915KA0 - KATANA™ Zirconia | 2026-03-09 YML T26 EW C |
| EKUR1259755KA0 - KATANA™ Zirconia | 2025-09-09 YML T26 A1 C |