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Elastic Mandibular Advancement (EMA) appliance

Modern Dental Laboratory (DG) Co., Ltd. · Model 003 · UDI-DI 06972677870030

LRK Prescription

510(k) clearances

2,783

Adverse events (1 deaths)

Recalls

108

Facilities

Description

The Elastic Mandibular Advancement appliance is a modified fuctional prthodontic appliance. The modifications are:1) clasps are not needed as the appliance is retained firmly to the teeth by pressure formed plastic into the undercut areas. Each tray holds the teeth in their present location not allowing tooth movement. 2) the bite is opened as in the SNOAR and NAPA appliances but not in one fixed position. Multiple bite openings are possible because of removable bite blocks or bite planes of varying thickness. 3) the mandible is advanced as in both the SNOAR and NAPA appliances except not in fixed position, but in various amounts of forward advancement because of removable, replaceable elastic bands or straps to pull the mandible forward.

Recalls

Date	Firm	Reason
2026-04-27	Prismatik Dentalcraft, Inc.	Due to device not having FDA Clearance
2025-10-09	Myofunctional Research Company USA	Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
2022-05-23	Dental Choice Holding Llc	The device was marketed and sold in the US without FDA clearance.
2017-09-01	Respire Medical	Potential for device breakage during use
2017-09-01	Respire Medical	Potential for device breakage during use
2017-09-01	Respire Medical	Potential for device breakage during use
2017-09-01	Respire Medical	Potential for device breakage during use
2017-09-01	Respire Medical	Potential for device breakage during use
2009-07-27	Medtronic 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
2009-07-27	Medtronic 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

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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.