The following data is part of a premarket notification filed by Shandong Huge Dental Material Corporation with the FDA for Flexible Block.
| Device ID | K213994 |
| 510k Number | K213994 |
| Device Name: | Flexible Block |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Shandong Huge Dental Material Corporation No. 68 Shanhai Road, Donggang District Rizhao City, CN 276800 |
| Contact | Maggie Zheng |
| Correspondent | Maggie Zheng Shandong Huge Dental Material Corporation No. 68 Shanhai Road, Donggang District Rizhao City, CN 276800 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-21 |
| Decision Date | 2022-03-04 |