MouthGuard

SOMATICS, LLC · Model EMGD · UDI-DI 00850298007041

JXL Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Reusable mouthguard intended to be placed between a patient’s teeth during medical procedures to protect teeth and oral structures. Constructed from rubber material and designed for repeated use with appropriate cleaning between uses.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.