| Primary Device ID | 04548190109012 |
| NIH Device Record Key | b8b3a278-6870-47a8-8394-7ba4770a4611 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Estelite Color |
| Version Model Number | 10901 |
| Company DUNS | 693552176 |
| Company Name | TOKUYAMA DENTAL CORPORATION |
| 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 | true |
| 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 | 1-877-378-3548 |
| info@tokuyama-us.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04548190109012 [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 | 2016-09-23 |
| 04548190109234 | Low Chroma Opaque |
| 04548190109227 | Medium Chroma Opaque |
| 04548190109210 | High Chroma Opaque |
| 04548190109203 | Pink Opaque |
| 04548190109197 | Lavender |
| 04548190109180 | Red |
| 04548190109173 | Dark Brown |
| 04548190109166 | Ochre |
| 04548190109159 | Gray |
| 04548190109142 | Yellow |
| 04548190109135 | Blue |
| 04548190109128 | White |
| 04548190109111 | Clear |
| 04548190109012 | Kit |