The following data is part of a premarket notification filed by Rizhao Huge Biomaterials Company, Ltd. with the FDA for Dual Cure Resin Cement.
| Device ID | K201790 |
| 510k Number | K201790 |
| Device Name: | Dual Cure Resin Cement |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-30 |
| Decision Date | 2020-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972220484363 | K201790 | 000 |
| 06972220484417 | K201790 | 000 |
| 06972220484400 | K201790 | 000 |
| 06972220484394 | K201790 | 000 |
| 06972220484387 | K201790 | 000 |
| 06972220484370 | K201790 | 000 |
| 06972220488644 | K201790 | 000 |