# K193570: Dental Pain Eraser

- Pathway: 510(k) (Special)
- Applicant: Synapse Dental
- Decided: Jan 17, 2020 after 25 days
- Product code: LWM (Device, Electrical Dental Anesthesia)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915717 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182947: Dental Pain Eraser, Synapse Dental, LLC (2019) Summary page 3.

## Indications for use
The Dental Pain Eraser DPE-C300 is intended to provide temporary dental anesthesia (pain relief) and is indicated for use before, during, or after dental and orthodontic procedures, and other sources of oral pain. It is intended for use by dental/orthodontic professionals for the alleviation of oral pain.

Source page: https://510kreport.com/device/K193570
Methodology: https://510kreport.com/methodology