# K192429: Dental Pain Eraser

- Pathway: 510(k) (Traditional)
- Applicant: Synapse Dental
- Decided: Jan 14, 2020 after 131 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 4.

## Indications for use
The Dental Pain Eraser DPE-T300 is intended to provide temporary dental anesthesia (pain relief). It is intended for prescriptive use only for the alleviation of oral pain for use by pediatric (10 years through 22 years of age) and adult patients for treatment at home. Pediatric patients 10 through 12 years of age must be supervised by an adult.

Source page: https://510kreport.com/device/K192429
Methodology: https://510kreport.com/methodology