| Primary Device ID | 04548190133949 |
| NIH Device Record Key | 0478f03d-fb96-4c30-9584-b210a88f5875 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Estelite Sigma Quick |
| Version Model Number | 13394 |
| Company DUNS | 693552176 |
| Company Name | TOKUYAMA DENTAL CORPORATION |
| Device Count | 5 |
| 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 |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04548190133949 [Primary] |
| GS1 | 94548190133942 [Unit of Use] |
| 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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |