The following data is part of a premarket notification filed by Epien Medical, Inc. with the FDA for Epien Root Canal Cleanser.
| Device ID | K123538 |
| 510k Number | K123538 |
| Device Name: | EPIEN ROOT CANAL CLEANSER |
| Classification | Cleanser, Root Canal |
| Applicant | EPIEN MEDICAL, INC. 700 THIRTEENTH ST. NW STUITE 200 Washington, DC 20005 |
| Contact | Jeffrey K Shapiro |
| Correspondent | Jeffrey K Shapiro EPIEN MEDICAL, INC. 700 THIRTEENTH ST. NW STUITE 200 Washington, DC 20005 |
| 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 | 2012-11-16 |
| Decision Date | 2013-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813110027337 | K123538 | 000 |
| 00860004740308 | K123538 | 000 |