AM Aligner

GUDID 00851085006117

Orthodontic teeth positioner, preformed

Primary Device ID	00851085006117
NIH Device Record Key	6624a203-2530-44f2-af25-f7321081f1b8
Commercial Distribution Status	In Commercial Distribution
Brand Name	AM Aligner
Version Model Number	700-1200-100
Company DUNS	963501148
Company Name	AIRWAY TECHNOLOGIES, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00851085006117 [Primary]
GS1	10851085006114 [Package] Package: package [10 Units] In Commercial Distribution

KMY	Positioner, Tooth, Preformed

Steralize Prior To Use	false
Device Is Sterile	false

00851085006209 - flexTAP	2023-06-02 The flex Thornton Adjustable Positioner™ (flexTAP™) is intended to reduce or alleviate nighttime snoring and sleep related b
00851085006216 - flexTAP Kit	2023-06-02 The flex Thornton Adjustable Positioner™ (flexTAP™) is intended to reduce or alleviate nighttime snoring and sleep related b
00851085006018 - MyTAP PAP Nasal Pillow Mask	2018-07-06
00851085006025 - MyTAP PAP Nasal Pillow Mask no headgear	2018-07-06
00851085006087 - TAP-3 oral appliance	2018-07-06
00851085006094 - TAP-3 Elite oral appliance	2018-07-06
00851085006100 - dreamTAP oral appliance	2018-07-06
00851085006131 - myTAP PAP Nasal Pillow Mask Frame	2018-07-06

Mark Image Registration \| Serial	Company Trademark Application Date
AM ALIGNER 97672348 not registered Live/Pending	Airway Technologies, LLC 2022-11-10