EPIEN Dental Cleanser
FDA 510(k) K201785 · Epien Medical, Inc.
510(k) numberK201785
Submission
- Device name
- EPIEN Dental Cleanser
- Applicant
- Epien Medical, Inc.
St. Paul, MN, US - Received
- June 30, 2020
- Decision date
- September 9, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KJJ – Cleanser, Root Canal
- Device class
- Unclassified
Other 510(k)s with product code KJJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250279 | RC-SwiftPrepKJJ · Traditional | Belport Company, Inc., Gingi-Pak | 07/02/2025SE |
| K241354 | Sealer SolventKJJ · Traditional | Inter-Med, Inc. | 08/27/2024SE |
| K211813 | TritonKJJ · Special | Inter-Med / Vista Dental | 08/18/2021SE |
| K193357 | V-MixKJJ · Traditional | Inter-Med/Vista Dental Products | 10/23/2020SE |
| K193409 | Vista Rinse, Vista Rinse PlusKJJ · Traditional | Inter-Med/Vista Dental Products | 09/09/2020SE |
| K200330 | RC-Prime Root Canal Preparation CreamKJJ · Traditional | Pac-Dent, Inc. | 07/06/2020SE |
| K173163 | ChlorCid, ChlorCid V, ChlorCid SurfKJJ · Traditional | Ultradent Products, Inc. | 02/09/2018SE |
| K162311 | Straumann PrefGelKJJ · Traditional | Institut Straumann AG | 03/07/2017SE |
| K160577 | PacEndo ChlorhexidineKJJ · Traditional | Pac-Dent International, Inc. | 07/25/2016SE |
| K153528 | PacEndo EDTAKJJ · Traditional | Pac-Dent International, Inc. | 02/01/2016SE |
More from Pac-Dent International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K123538 | Epien Root Canal CleanserKJJ · Traditional | 02/01/2013SE |
Questions and answers
When was EPIEN Dental Cleanser cleared by the FDA?
EPIEN Dental Cleanser (K201785) received a 510(k) decision of Substantially Equivalent on September 9, 2021, 436 days after the submission was received.
What is the product code of K201785?
The FDA product code is KJJ – Cleanser, Root Canal, a Unclassified device.