The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Glasionomer Fx-ii.
| Device ID | K031467 |
| 510k Number | K031467 |
| Device Name: | GLASIONOMER FX-II |
| Classification | Cement, Dental |
| Applicant | SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Contact | Robert Noble |
| Correspondent | Robert Noble SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-08 |
| Decision Date | 2003-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23532730 | K031467 | 000 |
| E23531930 | K031467 | 000 |
| E23531940 | K031467 | 000 |
| E23531950 | K031467 | 000 |
| E23532020 | K031467 | 000 |
| E23532030 | K031467 | 000 |
| E23532040 | K031467 | 000 |
| E23532050 | K031467 | 000 |
| E23532700 | K031467 | 000 |
| E23532710 | K031467 | 000 |
| E23532720 | K031467 | 000 |
| E23531920 | K031467 | 000 |