The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Hy-bond Polycarboxylate Temporary Dental Cement.
| Device ID | K002461 |
| 510k Number | K002461 |
| Device Name: | HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT |
| Classification | Cement, Dental |
| Applicant | SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Contact | Cindy Rhoades |
| Correspondent | Cindy Rhoades SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-10 |
| Decision Date | 2000-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23511760 | K002461 | 000 |
| E23511730 | K002461 | 000 |
| E23511620 | K002461 | 000 |
| E23511610 | K002461 | 000 |
| E23511600 | K002461 | 000 |