The following data is part of a premarket notification filed by Hangzhou Erran Technology Co., Ltd. with the FDA for Erran Dental Zirconia.
| Device ID | K182068 |
| 510k Number | K182068 |
| Device Name: | Erran Dental Zirconia |
| Classification | Powder, Porcelain |
| Applicant | Hangzhou Erran Technology Co., Ltd. Room F3022, Floor 3, Building 1 (south) No. 368 Liuhe Road Hangzhou, CN 310053 |
| Contact | Tingkai Li |
| Correspondent | Tingkai Li Hangzhou Erran Technology Co., Ltd. Room F3022, Floor 3, Building 1 (south) No. 368 Liuhe Road Hangzhou, CN 310053 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-01 |
| Decision Date | 2018-12-13 |
| Summary: | summary |