The following data is part of a premarket notification filed by Majestic Drug Co., Inc. with the FDA for Den Temp.
| Device ID | K821581 |
| 510k Number | K821581 |
| Device Name: | DEN TEMP |
| Classification | Zinc Oxide Eugenol |
| Applicant | MAJESTIC DRUG CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EMB |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-28 |
| Decision Date | 1982-06-14 |