The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Hi Dense, Glass Ionomer Silver Reinforced Restorative.
| Device ID | K945451 |
| 510k Number | K945451 |
| Device Name: | HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE |
| Classification | Cement, Dental |
| Applicant | SHOFU DENTAL CORP. 4025 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Contact | Bill Oestreich |
| Correspondent | Bill Oestreich SHOFU DENTAL CORP. 4025 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 | 1994-11-07 |
| Decision Date | 1995-02-27 |