The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Crystar Porcelain Margin Powder/liquid.
| Device ID | K840873 |
| 510k Number | K840873 |
| Device Name: | CRYSTAR PORCELAIN MARGIN POWDER/LIQUID |
| Classification | Powder, Porcelain |
| Applicant | SHOFU DENTAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-27 |
| Decision Date | 1984-04-25 |