| Primary Device ID | EKUR000013KA1 |
| NIH Device Record Key | d0cbdd0e-9c1f-44aa-806a-81d5becc6857 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-ETCHANT GEL |
| Version Model Number | #013-KA |
| 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 | EKUR000013KA1 [Primary] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-17 |
| EKUR1259730KA0 - KATANA™ Zirconia ONE | 2024-04-08 SPEED CROWN A1 |
| EKUR1259731KA0 - KATANA™ Zirconia ONE | 2024-04-08 SPEED CROWN A2 |
| EKUR1259732KA0 - KATANA™ Zirconia ONE | 2024-04-08 SPEED CROWN A3 |
| EKUR1259733KA0 - KATANA™ Zirconia ONE | 2024-04-08 SPEED CROWN A3.5 |
| EKUR1259734KA0 - KATANA™ Zirconia ONE | 2024-04-08 SPEED CROWN A4 |
| EKUR1259735KA0 - KATANA™ Zirconia ONE | 2024-04-08 SPEED CROWN B1 |
| EKUR1259736KA0 - KATANA™ Zirconia ONE | 2024-04-08 SPEED CROWN B2 |
| EKUR1259737KA0 - KATANA™ Zirconia ONE | 2024-04-08 SPEED CROWN B3 |