OMNICHROMA FLOW
GUDID 04548190102204
SYRINGE
TOKUYAMA DENTAL CORPORATION
Dental composite resin| Primary Device ID | 04548190102204 |
| NIH Device Record Key | c8cc1e43-d024-4805-a28f-77fc9edab0ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OMNICHROMA FLOW |
| Version Model Number | 10220 |
| 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 | 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 |
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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04548190102204 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193537
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 | 2020-09-08 |
| Device Publish Date | 2020-08-31 |
On-Brand Devices [OMNICHROMA FLOW]
| 04548190102204 | SYRINGE |
| 04548190102242 | SYRINGE SAMPLE KIT |
Trademark Results [OMNICHROMA FLOW]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNICHROMA FLOW 79275695 not registered Live/Pending |
TOKUYAMA CORPORATION 2019-09-17 |
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