The following data is part of a premarket notification filed by Qinhuangdao Silide Ceramic Technology Co., Ltd with the FDA for Ceramic Denture Zirconia Ceramics Block.
| Device ID | K181816 |
| 510k Number | K181816 |
| Device Name: | Ceramic Denture Zirconia Ceramics Block |
| Classification | Powder, Porcelain |
| Applicant | Qinhuangdao Silide Ceramic Technology Co., Ltd No. 1 Yanghe Rd., Quinhuangdao Economic And Technological Development Zone Qinhuangdao, CN 066000 |
| Contact | Lou Chunhua |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, CN 102401 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-09 |
| Decision Date | 2018-11-29 |
| Summary: | summary |