The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Glas Ionomer Cement.
| Device ID | K850913 |
| 510k Number | K850913 |
| Device Name: | GLAS IONOMER CEMENT |
| Classification | Cement, Dental |
| Applicant | SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Contact | Dale Tenny |
| Correspondent | Dale Tenny 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 | 1985-03-05 |
| Decision Date | 1985-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23511950 | K850913 | 000 |
| E23511300 | K850913 | 000 |
| E23511310 | K850913 | 000 |
| E23511320 | K850913 | 000 |
| E23511330 | K850913 | 000 |
| E23511340 | K850913 | 000 |
| E23511380 | K850913 | 000 |
| E23511400 | K850913 | 000 |
| E23511410 | K850913 | 000 |
| E23511420 | K850913 | 000 |
| E23511430 | K850913 | 000 |
| E23511440 | K850913 | 000 |
| E23511480 | K850913 | 000 |