The following data is part of a premarket notification filed by Shandong Huge Dental Material Corporation with the FDA for Denture Base Polymers.
| Device ID | K220680 |
| 510k Number | K220680 |
| Device Name: | Denture Base Polymers |
| 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 | 2022-03-08 |
| Decision Date | 2022-08-12 |