| Primary Device ID | 06972220484325 |
| NIH Device Record Key | 73076252-79d5-41e0-815b-ab53a67f4610 |
| Commercial Distribution Discontinuation | 2024-12-09 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Ceramic Coupling Agent |
| Version Model Number | 5ml |
| Company DUNS | 544452689 |
| Company Name | Rizhao HuGe Biomaterials Company, Ltd. |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06972220484325 [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 | 2024-12-17 |
| Device Publish Date | 2024-12-09 |
| 06972220484325 - Ceramic Coupling Agent | 2024-12-17 |
| 06972220484325 - Ceramic Coupling Agent | 2024-12-17 |
| 06972220489597 - Light Cure Veneer Cement | 2024-12-17 |
| 06972220488644 - Dual Cure Resin Cement | 2023-11-10 |
| 06972220489009 - TrusFIL-Flow Flowable Composite Restorative | 2023-11-10 |
| 06972220489030 - TrusFIL-Flow Flowable Composite Restorative | 2023-11-10 |
| 06972220489085 - TrusFIL Universal Composite Restorative | 2023-11-10 |
| 06972220489139 - TrusFIL Universal Composite Restorative | 2023-11-10 |
| 06972220484370 - Dual Cure Resin Cement | 2022-01-07 |