← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

MQC — Mouthguard, Prescription

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K253798Guangzhou Heygears IMC., Inc. · 510k2026-03-02
K250743Remvia · 510k2025-12-05
K251252Shandong Huge Dental Material Corporation · 510k2025-08-01
K241729Whip Mix Corporation · 510k2025-03-18
K243516Grindguard, Inc. · 510k2025-02-10

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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