Cleared Traditional

MYOHEALTH CLENCHING INHIBITOR (K040315) - FDA 510(k) Clearance

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

Submission Details

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
73d slower than avg
Panel avg: 127d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -