The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Glasionomer Base Cement.
| Device ID | K861005 |
| 510k Number | K861005 |
| Device Name: | GLASIONOMER BASE CEMENT |
| Classification | Cement, Dental |
| Applicant | SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Contact | Marty Dymek |
| Correspondent | Marty Dymek 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 | 1986-03-18 |
| Decision Date | 1986-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23511170 | K861005 | 000 |
| E23511160 | K861005 | 000 |
| E23511150 | K861005 | 000 |
| E23511140 | K861005 | 000 |
| E23511130 | K861005 | 000 |
| E23511110 | K861005 | 000 |
| E23511100 | K861005 | 000 |