Cleared Abbreviated

K043373 - DOLOTENS DENTAL TM 1

K043373 is an FDA 510(k) clearance for DOLOTENS DENTAL TM 1, manufactured by Neuromuscular Technologies, Inc.. The device is a Class 2 Dental device with product code KZM cleared through the Abbreviated 510(k) pathway after a 268-day FDA review.

K043373 · Neuromuscular Technologies, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
268d
Days
Class 2
Risk

K043373 is an FDA 510(k) clearance for the DOLOTENS DENTAL TM 1. Classified as Device, Muscle Monitoring (product code KZM), Class II - Special Controls.

Submitted by Neuromuscular Technologies, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on September 2, 2005 after a review of 268 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 890.1375 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K043373

510(k) Number K043373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2004
Decision Date September 02, 2005
Days to Decision 268 days
Submission Type Abbreviated
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
140d slower than avg
Panel avg: 128d · This submission: 268d
Pathway characteristics
Standards-based clearance path.

KZM Device Classification - Class 2, Special Controls

Product Code KZM Device, Muscle Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KZM Device, Muscle Monitoring

All 18
Devices cleared under the same product code (KZM) and FDA review panel - the closest regulatory comparables to K043373.
M-SCAN
K130158 · Bio-Research Associates, Inc. · Jul 2013
GRINDCARE MEASURE
K113677 · Medotech A/S · Apr 2012
BIOEMG III
K082927 · Bio-Research Associates, Inc. · Feb 2009
BITESTRIP
K030869 · S.L.P. , Ltd. · May 2004
BIOEMG II AND BIOJVA
K003176 · Bio-Research Associates, Inc. · Jan 2001
MODEL K7 EVALUATION DEVICE
K003287 · Myotronics-Noromed, Inc. · Nov 2000
K043373 · DOLOTENS DENTAL TM 1
Download PDF FDA Summary Neuromuscular Technol…