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 |