The following data is part of a premarket notification filed by E&d Dental Manufacturing Co. with the FDA for Zinc Oxide Eugenol Temporary Cement.
| Device ID | K883698 |
| 510k Number | K883698 |
| Device Name: | ZINC OXIDE EUGENOL TEMPORARY CEMENT |
| Classification | Cement, Dental |
| Applicant | E&D DENTAL MANUFACTURING CO. 6 HOFFMAN PLACE Hillside, NJ 07205 |
| Contact | Arthur Schwartz |
| Correspondent | Arthur Schwartz E&D DENTAL MANUFACTURING CO. 6 HOFFMAN PLACE Hillside, NJ 07205 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-30 |
| Decision Date | 1988-11-29 |