TAP (Thornton Adjustable Positioner)

FDA UDI

Class II (US FDA UDI)

by Johns Dental Laboratory

Identity

Trade Name: TAP (Thornton Adjustable Positioner) FDA UDI
Generic Name: Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 3014680794 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810002220050 FDA UDI
FDA Product Code: LRK FDA UDI
LQZ FDA UDI
LWF FDA UDI
GMDN Term: Mandible-repositioning sleep-disordered breathing orthosis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5570 FDA UDI
874.3900 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

TAP (Thornton Adjustable Positioner) by Johns Dental Laboratory — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Johns Dental Laboratory

Sources (1)

FDA UDI 7e94861e-f053-4d4a-82d9-e32ad4ecc77f 34 fields · synced May 30, 2026