The following data is part of a premarket notification filed by Epien Medical, Inc. with the FDA for Epien Dental Cleanser.
| Device ID | K201785 |
| 510k Number | K201785 |
| Device Name: | EPIEN Dental Cleanser |
| Classification | Cleanser, Root Canal |
| Applicant | EPIEN Medical, Inc. 4225 White Bear Parkway Suite 600 St. Paul, MN 55110 |
| Contact | Reginald Dupre |
| Correspondent | Carmelina G. Allis The Allis Law Firm, PLLC 2532 North Fourth Street, #620 Flagstaff, AZ 86004 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-30 |
| Decision Date | 2021-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840326420393 | K201785 | 000 |
| 00840326420379 | K201785 | 000 |
| 00840326420355 | K201785 | 000 |
| 00840326420331 | K201785 | 000 |