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TAP (Thornton Adjustable Positioner)

JOHN'S DENTAL LABORATORY INC · Model 3014680794 · UDI-DI 00810002220050

LRK LQZ LWF

510(k) clearances

2,966

Adverse events (1 deaths)

Recalls

108

Facilities

Description

A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.

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 placed
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

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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.