The following data is part of a premarket notification filed by Hocheng Corporation with the FDA for Hcg Zirconia Ceramic Block.
| Device ID | K193090 |
| 510k Number | K193090 |
| Device Name: | HCG Zirconia Ceramic Block |
| Classification | Powder, Porcelain |
| Applicant | Hocheng Corporation 1F.,No.398, Xingshan Rd., Neihu Dist. Taipei City, TW 11469 |
| Contact | Chieh-ju Huang |
| Correspondent | Chieh-ju Huang Hocheng Corporation 1F.,No.398, Xingshan Rd., Neihu Dist. Taipei City, TW 11469 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-06 |
| Decision Date | 2020-10-29 |