Cleared Traditional

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

K182947 · Synapse Dental, LLC · Dental device
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Optimized for regulatory review, auditing and printing
Mar 2019
Decision
154d
Days
-
Risk

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.

View all Synapse Dental, LLC devices

Submission Details

510(k) Number K182947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2018
Decision Date March 26, 2019
Days to Decision 154 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
27d slower than avg
Panel avg: 127d · This submission: 154d
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.