Cleared Special

K193570 - Dental Pain Eraser (FDA 510(k) Clearance)

K193570 · Synapse Dental · Dental device
Jan 2020
Decision
25d
Days
-
Risk

K193570 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 17, 2020, 25 days after receiving the submission on December 23, 2019.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K193570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date January 17, 2020
Days to Decision 25 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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