The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Hy-bond Polycarboxylate Cement.
| Device ID | K810764 |
| 510k Number | K810764 |
| Device Name: | HY-BOND POLYCARBOXYLATE CEMENT |
| Classification | Cement, Dental |
| Applicant | SHOFU DENTAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-23 |
| Decision Date | 1981-06-12 |