510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K040315Substantially Equivalent

Myohealth Clenching Inhibitor

Mci-Myohealth Systems, Mission Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040315 is the FDA 510(k) clearance record for MYOHEALTH CLENCHING INHIBITOR, cleared for Mci-Myohealth Systems on under FDA product code MQC (Mouthguard, Prescription). FDA records list one 510(k) clearance for Mci-Myohealth Systems. As of , FDA records show no recalls naming K040315.

Clearance record

Decision date
Received
(200 days to decision)
Product code
MQC Mouthguard, Prescription
Device class
Unclassified
Review panel
Unknown
Applicant
Mci-Myohealth Systems 26552 Tampico Pl., Mission Viejo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQC

Trailing 12 months
3 clearances under product code MQC in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQC, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260