The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Crystalloy-p.
| Device ID | K810594 |
| 510k Number | K810594 |
| Device Name: | CRYSTALLOY-P |
| Classification | Alloy, Metal, Base |
| Applicant | SHOFU DENTAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-06 |
| Decision Date | 1981-03-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CRYSTALLOY-P 73310765 1237980 Dead/Cancelled |
Shofu Dental Corporation 1981-05-18 |