The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Glasionomer Cement Cx Plus.
| Device ID | K982461 |
| 510k Number | K982461 |
| Device Name: | GLASIONOMER CEMENT CX PLUS |
| Classification | Cement, Dental |
| Applicant | SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Contact | Thomas D Yankelitis |
| Correspondent | Thomas D Yankelitis 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 | 1998-07-15 |
| Decision Date | 1998-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23532770 | K982461 | 000 |
| E23511870 | K982461 | 000 |
| E23511690 | K982461 | 000 |
| E23511680 | K982461 | 000 |
| E23511670 | K982461 | 000 |
| E23511660 | K982461 | 000 |