Cleared Special

MODEL K7 EVALUATION DEVICE (K003287) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K003287 · Myotronics-Noromed, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
17d
Days
Class 2
Risk

K003287 is an FDA 510(k) clearance for the MODEL K7 EVALUATION DEVICE. Classified as Device, Muscle Monitoring (product code KZM), Class II - Special Controls.

Submitted by Myotronics-Noromed, Inc. (Tukwila, US). The FDA issued a Cleared decision on November 6, 2000 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 890.1375 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Myotronics-Noromed, Inc. devices

Submission Details

510(k) Number K003287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2000
Decision Date November 06, 2000
Days to Decision 17 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 127d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.