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

FDA 510(k) Submission Details - K192429

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.

LWM Device Classification - Class 0,

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

All 7
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
TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
K011001 · Satelec · Jun 2001
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