Cleared Traditional

K040315 - MYOHEALTH CLENCHING INHIBITOR

K040315 · Mci-Myohealth Systems · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
200d
Days
-
Risk

K040315 is an FDA 510(k) clearance for the MYOHEALTH CLENCHING INHIBITOR. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Mci-Myohealth Systems (Mission Viejo, US). The FDA issued a Cleared decision on August 27, 2004 after a review of 200 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 Mci-Myohealth Systems devices

FDA 510(k) Submission Details - K040315

510(k) Number K040315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2004
Decision Date August 27, 2004
Days to Decision 200 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 128d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 71
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K040315.
DEN TEK NIGHTGUARD
K063483 · Den Tek Oral Care, Inc. · Jan 2007
MOUTHGUARD AND ALIGNER MATERIALS
K062828 · Dentsply Intl., Inc. · Nov 2006
DOCTOR'S NIGHTGUARD
K053580 · Dental Concepts, LLC · Mar 2006
EZ SPLINT & EZ SPLINT PM
K022809 · Power Products, Inc.-Splintek · Oct 2003
PRIMOSPLINT SYSTEM
K030832 · Cosmedent, Inc. · Sep 2003
DENTAL PROTECTOR
K024261 · Dental Concepts, LLC · Mar 2003