FDA.reportPublic FDA data

AM Aligner

Primary DI
00851085006117
Brand
AM Aligner
Company
AIRWAY TECHNOLOGIES, LLC
Model
700-1200-100
Published
2016-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KMYPositioner, Tooth, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851085006114PackageGS110In Commercial Distribution
00851085006117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085108500611410851085006114
00851085006117008510850061178510850061170851085006117

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic teeth positioner, preformedA prefabricated dental device, typically made of plastic, that is an impression of a perfected bite used to prevent a patient's teeth from shifting position, or to move teeth to a final position, after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963501148
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851085006247Nylon flexTAP Oral ApplianceTAP-NYL-0012026-05-08
00851085006254Nylon flexTAP Oral Appliance KitKIT NYL1002026-05-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800142101007Tera TainerGraphy Inc.KMY2026-05-14
H66842000141KeyPrintKeystone IndustriesKMY2024-09-26
H66841101411KeyPrintKeystone IndustriesKMY2023-09-25
H66842201511KeyPrintKeystone IndustriesKMY2023-09-25
08719425509549Vertex-Dental BVVertex-Dental B.V.KMY2023-06-20
08719425509556NextDentVertex-Dental B.V.KMY2023-06-15
H66842000111KeyPrintKeystone IndustriesKMY2023-02-20
H66842001611KeyPrintKeystone IndustriesKMY2023-02-20
H66842200111KeyPrintKeystone IndustriesKMY2023-02-20
H66842201141HeyGearsKeystone IndustriesKMY2023-02-20
EPRCD1001609PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001610PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001611PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
H668210241American DentalKeystone IndustriesKMY2022-11-30
H668210251American DentalKeystone IndustriesKMY2022-11-30
H668210261American DentalKeystone IndustriesKMY2022-11-30
H668210271American DentalKeystone IndustriesKMY2022-11-30
H668210341American DentalKeystone IndustriesKMY2022-11-30
EPRCD1001703PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRCD1001704PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRC66077916dima Print Splint clear pro3dure medical GmbHKMY2021-11-25
EPRCD1000800PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1000801PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1001491PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001492PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001493PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001701PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
EPRCD1001702PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
ERKO5142052ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5142072ErkolenErkodent Erich Kopp GmbHKMY2021-09-21