ESTELITE UNIVERSAL FLOW
GUDID 04548190139781
High PLT A3.5
TOKUYAMA DENTAL CORPORATION
Dental composite resin| Primary Device ID | 04548190139781 |
| NIH Device Record Key | 1bc2265a-6e71-455e-9553-8f9d0be9f20e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ESTELITE UNIVERSAL FLOW |
| Version Model Number | 13978 |
| Company DUNS | 693552176 |
| Company Name | TOKUYAMA DENTAL CORPORATION |
| Device Count | 20 |
| 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 |
Customer Support Contacts
| 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 | |
| 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 |
Operating and Storage Conditions
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04548190139781 [Primary] |
| GS1 | 94548190139784 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180613
FDA Product Code
| EBF | Material, Tooth Shade, Resin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-10 |
| Device Publish Date | 2018-08-09 |
On-Brand Devices [ESTELITE UNIVERSAL FLOW]
| 04548190139996 | SuperLow PLT A5 |
| 04548190139989 | SuperLow PLT A4 |
| 04548190139972 | SuperLow PLT A3.5 |
| 04548190139965 | SuperLow PLT A3 |
| 04548190139958 | SuperLow PLT A2 |
| 04548190139941 | SuperLow PLT A1 |
| 04548190139934 | Medium PLT BW |
| 04548190139927 | Medium PLT CE |
| 04548190139910 | Medium PLT OPA4 |
| 04548190139903 | Medium PLT OPA3 |
| 04548190139897 | Medium PLT OPA2 |
| 04548190139880 | Medium PLT B3 |
| 04548190139873 | Medium PLT A5 |
| 04548190139866 | Medium PLT A4 |
| 04548190139859 | Medium PLT A3.5 |
| 04548190139842 | Medium PLT A3 |
| 04548190139835 | Medium PLT A2 |
| 04548190139828 | Medium PLT A1 |
| 04548190139811 | High PLT OPA4 |
| 04548190139804 | High PLT OPA3 |
| 04548190139798 | High PLT OPA2 |
| 04548190139781 | High PLT A3.5 |
| 04548190139774 | High PLT A3 |
| 04548190139767 | High PLT A2 |
| 04548190139750 | High PLT A1 |
| 04548190138999 | SuperLow L-SYR A5 |
| 04548190138982 | SuperLow L-SYR A4 |
| 04548190138975 | SuperLow L-SYR A3.5 |
| 04548190138968 | SuperLow L-SYR A3 |
| 04548190138951 | SuperLow L-SYR A2 |
| 04548190138944 | SuperLow L-SYR A1 |
| 04548190138937 | Medium L-SYR BW |
| 04548190138920 | Medium L-SYR CE |
| 04548190138913 | Medium L-SYR OPA4 |
| 04548190138906 | Medium L-SYR OPA3 |
| 04548190138890 | Medium L-SYR OPA2 |
| 04548190138883 | Medium L-SYR B3 |
| 04548190138876 | Medium L-SYR A5 |
| 04548190138869 | Medium L-SYR A4 |
| 04548190138852 | Medium L-SYR A3.5 |
| 04548190138845 | Medium L-SYR A3 |
| 04548190138838 | Medium L-SYR A2 |
| 04548190138821 | Medium L-SYR A1 |
| 04548190138814 | High L-SYR OPA4 |
| 04548190138807 | High L-SYR OPA3 |
| 04548190138791 | High L-SYR OPA2 |
| 04548190138784 | High L-SYR A3.5 |
| 04548190138777 | High L-SYR A3 |
| 04548190138760 | High L-SYR A2 |
| 04548190138753 | High L-SYR A1 |
Trademark Results [ESTELITE UNIVERSAL FLOW]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ESTELITE UNIVERSAL FLOW 79190057 5178696 Live/Registered |
TOKUYAMA CORPORATION 2016-05-12 |
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