The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Crystar Porcelain.
| Device ID | K833643 |
| 510k Number | K833643 |
| Device Name: | CRYSTAR PORCELAIN |
| Classification | Powder, Porcelain |
| Applicant | SHOFU DENTAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-17 |
| Decision Date | 1983-12-29 |