FDA.reportPublic FDA data

ORTHO ALIGNER TRAY SEATERS

Primary DI
D89260705400322
Brand
ORTHO ALIGNER TRAY SEATERS
Company
MAXILL, INC.
Model
6070540032
Published
2022-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ECSPusher, Band, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECSPusher, Band, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D89260705400323PackageHIBCC2000In Commercial Distribution
D89260705400322PrimaryHIBCC0
D89260705400321Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic aligner/retainer seater, single-useA small cylindrical pledget intended to be used to facilitate placement and proper seating of an orthodontic progressive aligner or teeth retainer (positioner), by being placed between the partially-aligned aligner/retainer and the opposing set of teeth, allowing the patient to bite down on the device to push the aligner/retainer into place. This is a single-use device.

Regulatory Flags#

DUNS number
079343581
Device count
20
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D89260705600570AUTOCLAVE TAPE60705600572022-09-19
D89260705600580AUTOCLAVE TAPE60705600582022-09-19
D89260705600590AUTOCLAVE TAPE60705600592022-09-19
00060705811240u-test SI Steam Sterilization Integrator811242016-10-17
D89260705533181POLYALL CURING LIGHT SLEEVE60705533182022-07-22
D89260705533182POLYALL CURING LIGHT SLEEVE60705533182022-07-22
D89260705533191POLYALL CURING LIGHT SLEEVE60705533192022-07-22
D89260705533192POLYALL CURING LIGHT SLEEVE60705533192022-07-22
D89260705535201COVERMAX OPTIMUM HEADREST COVER60705535202022-10-20
D8926070553525BU1COVERMAX OPTIMUM HEADREST COVER6070553525BU2022-10-20
D8926070553525GN1COVERMAX OPTIMUM HEADREST COVER6070553525GN2022-10-20
D8926070553525LV1COVERMAX OPTIMUM HEADREST COVER6070553525LV2022-10-20
D89260705533601PHOSPHOR PLATE BARRIER ENVELOPES60705533602022-07-22
D89260705533602PHOSPHOR PLATE BARRIER ENVELOPES60705533602022-07-22
D89260705533611PHOSPHOR PLATE BARRIER ENVELOPES60705533612022-07-22
D89260705533612PHOSPHOR PLATE BARRIER ENVELOPES60705533612022-07-22
D89260705533621PHOSPHOR PLATE BARRIER ENVELOPES60705533622022-07-22
D89260705533622PHOSPHOR PLATE BARRIER ENVELOPES60705533622022-07-22
D89260705533651PHOSPHOR PLATE BARRIER ENVELOPES60705533652022-07-22
D89260705533652PHOSPHOR PLATE BARRIER ENVELOPES60705533652022-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840018674639Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECS2026-05-05
00840018662087Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECS2026-01-29
00840018662155Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECS2026-01-29
00190707193317Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193324Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193331Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193348Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193355Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193362Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193379Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193386Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193393Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00371347019797Advance Dental ProductsThe Atlanta Dental Supply CompanyECS2025-10-02
00371347019803Advance Dental ProductsThe Atlanta Dental Supply CompanyECS2025-10-02
00889813066041Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCECS2024-11-30
00850058951362Amtouch Aligner ChewiesAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECS2024-10-08
00850058951379Amtouch Aligner ChewiesAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECS2024-10-08
00885797097293SchweickhardtRmo, Inc.ECS2024-08-19
00840105223597ZOLL DENTALZoll-DentalECS2024-07-29
00843471151273Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
00843471151280Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
00843471151297Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
00843471151303Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
00843471151310Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
07908611206053ORTHOCHEWIEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECS2024-02-27
08800075622747OSUNG MNDOSUNG MND Co., Ltd.ECS2024-02-19
07898506814176QuinelatoSchobell Industrial LtdaECS2023-07-05
10889950042646Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCECS2023-06-27
10889950083335Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCECS2023-06-27
10889950083373Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCECS2023-06-27