The following data is part of a premarket notification filed by Jedental Co., Inc. with the FDA for Zoe Cement (zinc Oxide & Eugenol Cement).
| Device ID | K933543 |
| 510k Number | K933543 |
| Device Name: | ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) |
| 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 | 1993-07-20 |
| Decision Date | 1993-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816526021623 | K933543 | 000 |
| 00816526021227 | K933543 | 000 |
| 00816526021210 | K933543 | 000 |
| 00816526020213 | K933543 | 000 |
| 00816526020206 | K933543 | 000 |
| 00816526020190 | K933543 | 000 |
| 00816526020183 | K933543 | 000 |