The following data is part of a premarket notification filed by Crown Porcelain Dental Technology Co., Ltd. with the FDA for Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-shaded Blank.
| Device ID | K180252 |
| 510k Number | K180252 |
| Device Name: | Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank |
| Classification | Powder, Porcelain |
| Applicant | Crown Porcelain Dental Technology Co., Ltd. 5F.-1, No. 189, Sec 2, Keelung Rd., Xinyi Dist. Taipei City, CN 110 |
| Contact | Chu Lien Fan |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd. P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-30 |
| Decision Date | 2018-04-24 |
| Summary: | summary |