Cleared Traditional

K192429 - Dental Pain Eraser (FDA 510(k) Clearance)

K192429 · Synapse Dental · Dental device
Jan 2020
Decision
131d
Days
-
Risk

K192429 is an FDA 510(k) clearance for the Dental Pain Eraser. This device is classified as a Device, Electrical Dental Anesthesia.

Submitted by Synapse Dental (Cranston, US). The FDA issued a Cleared decision on January 14, 2020, 131 days after receiving the submission on September 5, 2019.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K192429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2019
Decision Date January 14, 2020
Days to Decision 131 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LWM - Device, Electrical Dental Anesthesia
Device Class -