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The Moses TM Appliance

Modern Dental Laboratory (DG) Co., Ltd. · Model 002 · UDI-DI 06972677870023

LRK Prescription
10
510(k) clearances
2,783
Adverse events (1 deaths)
10
Recalls
108
Facilities

Description

The Moses appliance is intended for use on adult patients 18 years of age and older as an aid for the reduction and /or alleviation of snoring and mild to moderate obstrctive sleep apnea.

Recalls

DateFirmReason
2026-04-27Prismatik Dentalcraft, Inc.Due to device not having FDA Clearance
2025-10-09Myofunctional Research Company USADue to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
2022-05-23Dental Choice Holding LlcThe device was marketed and sold in the US without FDA clearance.
2017-09-01Respire MedicalPotential for device breakage during use
2017-09-01Respire MedicalPotential for device breakage during use
2017-09-01Respire MedicalPotential for device breakage during use
2017-09-01Respire MedicalPotential for device breakage during use
2017-09-01Respire MedicalPotential for device breakage during use
2009-07-27Medtronic Xomed, Inc.Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed
2009-07-27Medtronic Xomed, Inc.Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently place

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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.