# K201785: EPIEN Dental Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Epien Medical, Inc.
- Decided: Sep 9, 2021 after 436 days
- Product code: KJJ (Cleanser, Root Canal)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
EPIEN DENTAL CLEANSER is indicated for the following uses: 1) Caries Restoration Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of exposed dentin surfaces in cavity preparations to assist in the removal of contaminated debris and smear-layer. 2) Chronic Periodontitis Treatment Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of tooth root surfaces during periodontal debridement procedures (scaling and root planing) to help with the removal of contaminated debris from the sulcus.

Source page: https://510kreport.com/device/K201785
Methodology: https://510kreport.com/methodology