Cleared Traditional

K192429 - Dental Pain Eraser

K192429 · Synapse Dental · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

Regulatory Peers - LWM Device, Electrical Dental Anesthesia

Devices cleared under the same product code (LWM) and FDA review panel - the closest regulatory comparables to K192429.
Dental Pain Eraser
K193570 · Synapse Dental · Jan 2020
Dental Pain Eraser
K182947 · Synapse Dental, LLC · Mar 2019
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670
K935304 · 3M Company · Mar 1994
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION
K935082 · 3M Company · Jan 1994
3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS
K935085 · 3M Company · Jan 1994
3M DENTAL ELECTRONIC ANESTHESIA SYSTEM
K920119 · 3M Company · May 1992