The following data is part of a premarket notification filed by Rizhao Huge Biomaterials Company, Ltd. with the FDA for Trusfil-flow Flowable Composite Restorative.
| Device ID | K221510 |
| 510k Number | K221510 |
| Device Name: | TrusFIL-Flow Flowable Composite Restorative |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Rizhao HuGe Biomaterials Company, Ltd. No.2 North Zhaoyang Road, District Of Donggang Rizhao City, CN 276800 |
| Contact | Maggie Zheng |
| Correspondent | Maggie Zheng Rizhao HuGe Biomaterials Company, Ltd. No.2 North Zhaoyang Road, District Of Donggang Rizhao City, CN 276800 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-24 |
| Decision Date | 2022-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972220489030 | K221510 | 000 |
| 06972220489009 | K221510 | 000 |