K182947 - Dental Pain Eraser (FDA 510(k) Clearance)

K182947 is an FDA 510(k) clearance for the Dental Pain Eraser. Classified as Device, Electrical Dental Anesthesia (product code LWM).

Submitted by Synapse Dental, LLC (Cranston, US). The FDA issued a Cleared decision on March 26, 2019 after a review of 154 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.