The following data is part of a premarket notification filed by Chengdu Besmile Biotechnology Co.,ltd. with the FDA for Zirconia Dental Ceramics.
| Device ID | K170894 |
| 510k Number | K170894 |
| Device Name: | Zirconia Dental Ceramics |
| Classification | Powder, Porcelain |
| Applicant | CHENGDU BESMILE BIOTECHNOLOGY CO.,LTD. NO.1666, Chenglong Road Section Two, Economic-technical Development Zone Chengdu, CN 610100 |
| Contact | Moushan Liu |
| Correspondent | Moushan Liu CHENGDU BESMILE BIOTECHNOLOGY CO.,LTD. NO.1666, Chenglong Road Section Two, Economic-technical Development Zone Chengdu, CN 610100 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-27 |
| Decision Date | 2017-08-01 |