Cleared Traditional

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

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

K192429 is an FDA 510(k) clearance for the Dental Pain Eraser. Classified as Device, Electrical Dental Anesthesia (product code LWM).

Submitted by Synapse Dental (Cranston, US). The FDA issued a Cleared decision on January 14, 2020 after a review of 131 days - within the typical 510(k) review window.

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.

View all Synapse Dental devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 127d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWM Device, Electrical Dental Anesthesia
Device Class -

Regulatory Consultant

Experien Group, LLC
Valerie Defiesta-NG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.