| Primary Device ID | 04548190161485 |
| NIH Device Record Key | b80c0ff7-b876-4c7d-9aed-19af34f14cad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ESTECEM II |
| Version Model Number | 16148 |
| 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 | |
| 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 10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04548190161485 [Primary] |
| KLE | Agent, Tooth Bonding, 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 | 2018-09-03 |
| Device Publish Date | 2018-08-01 |
| 04548190161881 | PASTE WHITE OPAQUE |
| 04548190161782 | PASTE BROWN |
| 04548190161683 | PASTE CLEAR |
| 04548190161584 | PASTE UNIVERSAL |
| 04548190161485 | KIT UNIVERSAL |