The following data is part of a premarket notification filed by De Corematrix Co.ltd. with the FDA for Dental Zirconia Blocks.
| Device ID | K192262 |
| 510k Number | K192262 |
| Device Name: | Dental Zirconia Blocks |
| Classification | Powder, Porcelain |
| Applicant | De Corematrix Co.Ltd. No.40 NanBeigang Road, HuKou County Jiujiang, CN 332599 |
| Contact | Kaixuan Liu |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng Rd.,Pudong 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 | 2019-08-21 |
| Decision Date | 2020-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974208580005 | K192262 | 000 |