FDA.reportPublic FDA data

Nylon flexTAP Oral Appliance Kit

Primary DI
00851085006254
Brand
Nylon flexTAP Oral Appliance Kit
Company
AIRWAY TECHNOLOGIES, LLC
Model
KIT NYL100
Device 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.
Published
2026-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252374000Nylon flexTAP(R)Airway Technologies D/B/A Airway Management2025-09-11LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851085006254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851085006254008510850062548510850062540851085006254

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-4 Degrees Fahrenheit122 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
2143690978ejarrett@tapintosleep.com

Regulatory Flags#

DUNS number
963501148
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851085006247Nylon flexTAP Oral ApplianceTAP-NYL-0012026-05-08
00851085006209flexTAPTAP-FLEX-1002023-05-25
00851085006216flexTAP KitFLEXTAP2023-05-25
00851085006018MyTAP PAP Nasal Pillow MaskPAP-NP1-0002016-08-13
00851085006025MyTAP PAP Nasal Pillow Mask no headgearPAP-NP1-0012016-08-13
00851085006087TAP-3 oral applianceTAP-32016-08-12
00851085006094TAP-3 Elite oral applianceTAP-3 Elite2016-08-12
00851085006100dreamTAP oral appliancedreamTAP2016-08-13
00851085006131myTAP PAP Nasal Pillow Mask FramePAP-NP1-0022016-12-29
00851085006001MyTAP oral appliancemytap10002016-08-10
00851085006032TAP-1 componentskit082016-08-13
00851085006049TAP-3 componentskit121742016-08-13
00851085006056TAP-3 Elite componentskit1232016-08-13
00851085006063dreamTAP componentskitdr2016-08-13
00851085006070TAP-1 oral applianceTAP-12016-08-12
00851085006117AM Aligner700-1200-1002016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850077473005EMA NOW PATIENT STARTER KITSEMA SLEEP INCORPORATEDLRK2026-08-14
00850077473012EMA Serena Patient Starter kitsEMA SLEEP INCORPORATEDLRK2026-08-14
00850077473043INDIVIDUAL EMA STRAPS(EMAST13W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473050Individual EMA Straps(EMAST14W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473067Individual EMA Straps(EMAST15W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473074Individual EMA Straps(EMAST16W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473081Individual EMA Straps(EMAST17W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473098Individual EMA Straps(EMAST18W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473104Individual EMA Straps(EMAST19W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473111Individual EMA Straps(EMAST20W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473128Individual EMA Straps(EMAST21W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473135Individual EMA Straps(EMAST13Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473142Individual EMA Straps(EMAST14Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473159Individual EMA Straps(EMAST15Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473166Individual EMA Straps(EMAST16Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473173Individual EMA Straps(EMAST17Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473180Individual EMA Straps(EMAST18Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473197Individual EMA Straps(EMAST19Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473203Individual EMA Straps(EMAST20Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473210Individual EMA Straps(EMAST21Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473227Individual EMA Straps(EMAST13B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473234Individual EMA Straps(EMAST14B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473241Individual EMA Straps(EMAST15B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473258Individual EMA Straps(EMAST16B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473265Individual EMA Straps(EMAST17B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473272Individual EMA Straps(EMAST18B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473289Individual EMA Straps(EMAST19B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473296Individual EMA Straps(EMAST20B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473302Individual EMA Straps(EMAST21B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473319Individual EMA Straps(EMAST13C)EMA SLEEP INCORPORATEDLRK2026-08-14