Device
The Nylon flex Thornton Adjustable Positioner (Nylon flexTAP) is intended to reduce or alleviate nighttime snoring and sleep related breathing disorders including obstructive sleep...
Manufacturer
AIRWAY TECHNOLOGIES, LLC
AIRWAY TECHNOLOGIES, LLC
Model: TAP-NYL-001
DI: 00851085006247
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
The Nylon flex Thornton Adjustable Positioner (Nylon flexTAP) is intended to reduce or alleviate nighttime snoring and sleep related breathing disorders including obstructive sleep apnea (OSA). The Nylon flexTAP is a custom-fit oral device intended to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA). The Nylon flexTAP device consists of an Upper Tray that fits over the upper teeth and Lower Tray that fits over the lower teeth.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3d4ab222-4737-4109-803e-24f6b85a4c1c
Distribution Status:
In Commercial Distribution
DUNS Number:
963501148
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
Yes
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00851085006247
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47526
Name: Mandible-repositioning sleep-disordered breathing orthosis
Definition:
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 Product Codes
LRK
Device, Anti-Snoring
Premarket Submissions
Submission Number:
K252374
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Storage Handling - Storage Handling Low - @attributes - Value:
-4
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Storage Handling - Storage Handling High - @attributes - Value:
122
Storage Handling - Storage Handling Type:
Storage Environment Temperature