| Primary Device ID | 04548190165438 |
| NIH Device Record Key | fbc064c8-3d34-4c08-8387-775095c0e84b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tokuso Ceramic Primer |
| Version Model Number | 16543 |
| 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 | 04548190165438 [Primary] |
| EMA | Cement, Dental |
| 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 |
| 04548190102242 - OMNICHROMA FLOW | 2024-11-04 SYRINGE SAMPLE KIT |
| 04548190107629 - Brush No.24 | 2022-10-03 Brush for composite |
| 94548190122717 - PALFIQUE ESTELITE LV Syringe Tip | 2022-10-03 Dispensing tip for flowable composite |
| 04548190127405 - TOKUYAMA Dispensing Tip | 2022-10-03 Dispensing tip for flowable composite |
| 94548190137995 - TOKUYAMA Plastic Tip | 2022-10-03 Plastic dispensing tip for flowable composite |
| 04548190146727 - Disposable Applicator Tip & Handle Set | 2022-10-03 Disposable Applicator Tip & Handle for One-Up Bond F Plus |
| 94548190161938 - Cement Mixing Tip | 2022-10-03 Mixing tip for cement |
| 04548190233724 - TOKUYAMA DISPENSER II | 2022-10-03 Dispensor for Sofreliner |