The following data is part of a premarket notification filed by Huge Dental Material Co., Ltd. with the FDA for Pmma Block.
| Device ID | K201683 |
| 510k Number | K201683 |
| Device Name: | PMMA Block |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Huge Dental Material Co., Ltd. Middle Shanhai Road Rizhao City, CN 276800 |
| Contact | Maggie Zheng |
| Correspondent | Maggie Zheng Huge Dental Material Co., Ltd. Middle Shanhai Road Rizhao City, CN 276800 |
| Product Code | EBG |
| Subsequent Product Code | EBI |
| Subsequent Product Code | MQC |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-22 |
| Decision Date | 2020-11-03 |
| Summary: | summary |