The following data is part of a premarket notification filed by Dentimedic with the FDA for Dentimedic Dental Emergency Kit.
| Device ID | K861681 |
| 510k Number | K861681 |
| Device Name: | DENTIMEDIC DENTAL EMERGENCY KIT |
| Classification | Zinc Oxide Eugenol |
| Applicant | DENTIMEDIC 102 EIGHTH ST. Pocomoke City, MD 21851 |
| Contact | Leishear, Dmd |
| Correspondent | Leishear, Dmd DENTIMEDIC 102 EIGHTH ST. Pocomoke City, MD 21851 |
| Product Code | EMB |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-01 |
| Decision Date | 1986-09-23 |