The following data is part of a premarket notification filed by Jedental Co., Inc. with the FDA for Jedental Glass Ionomer Cement And Liner.
| Device ID | K934073 |
| 510k Number | K934073 |
| Device Name: | JEDENTAL GLASS IONOMER CEMENT AND LINER |
| Classification | Cement, Dental |
| Applicant | JEDENTAL CO., INC. 324 SECOND ST. PIKE Southampton, PA 18966 |
| Contact | John Wong |
| Correspondent | John Wong JEDENTAL CO., INC. 324 SECOND ST. PIKE Southampton, PA 18966 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-20 |
| Decision Date | 1994-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816526020107 | K934073 | 000 |
| 00816526020091 | K934073 | 000 |
| 00816526020084 | K934073 | 000 |
| 00816526020077 | K934073 | 000 |
| 00816526020060 | K934073 | 000 |