FDA.reportPublic FDA data

Protraction Facemask

Primary DI
00190746057946
Brand
Protraction Facemask
Company
AMERICAN ORTHODONTICS CORPORATION
Model
852-800
Catalog number
852-800
Device description
PROTRACTION FACE MASK
Published
2022-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZBHeadgear, extraoral, orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZBHeadgear, Extraoral, OrthodonticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190746057946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746057946001907460579461907460579460190746057946

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic chin cap/cupA dental device component of an extraoral orthodontic headgear designed to help reduce/correct mandibular prognathism by applying reverse pull force to the chin, via tight attachment to the headgear head straps. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags#

DUNS number
044668515
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190746067549PowerScope852-016539852-0165392026-03-24
00190746067563PowerScope852-016540852-0165402026-03-24
00190746067587PowerScope852-030576852-0305762026-03-24
00190746153273PowerScope852-016541852-0165412026-03-24
00190746202742PowerScope852-016538852-0165382026-03-24
00190746202759PowerScope852-016537852-0165372026-03-24
00190746191602Empower Bracket475-1112VSCC475-1112VSCC2026-03-23
00190746191619Empower Bracket475-128VSCC475-128VSCC2026-03-23
00190746191626Empower Bracket475-2112VSCC475-2112VSCC2026-03-23
00190746191633Empower Bracket475-228VSCC475-228VSCC2026-03-23
00190746191640Empower Bracket475-310VSCC475-310VSCC2026-03-23
00190746191657Empower Bracket475-410VSCC475-410VSCC2026-03-23
00190746191664Empower Bracket585-130BVSCC585-130BVSCC2026-03-23
00190746191671Empower Bracket585-140BVSCC585-140BVSCC2026-03-23
00190746191688Empower Bracket585-140VSCC585-140VSCC2026-03-23
00190746191695Empower Bracket585-230BVSCC585-230BVSCC2026-03-23
00190746191701Empower Bracket585-240BVSCC585-240BVSCC2026-03-23
00190746191718Empower Bracket585-240VSCC585-240VSCC2026-03-23
00190746191725Empower Bracket585-330BVSCC585-330BVSCC2026-03-23
00190746191732Empower Bracket585-340BVSCC585-340BVSCC2026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10190707192874Ortho Technology®Ortho Organizers, Inc.DZB2025-10-23
00190707192884Ortho Technology®Ortho Organizers, Inc.DZB2025-10-23
00190707192891Ortho Technology®Ortho Organizers, Inc.DZB2025-10-23
00190707192907Ortho Technology®Ortho Organizers, Inc.DZB2025-10-23
00190707192914Ortho Technology®Ortho Organizers, Inc.DZB2025-10-23
00190707192921Ortho Technology®Ortho Organizers, Inc.DZB2025-10-23
00190707192938Ortho Technology®Ortho Organizers, Inc.DZB2025-10-23
00190707192945Ortho Technology®Ortho Organizers, Inc.DZB2025-10-23
00190707192952Ortho Technology®Ortho Organizers, Inc.DZB2025-10-23
00190707149024Ortho Technology®Ortho Organizers, Inc.DZB2025-10-01
00190707108144Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
00190707108151Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
00190707108168Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
00190707108175Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
00190707108182Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
00190707108199Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
00190707108205Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
00190707108212Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
00190707108229Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
00190707108236Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
00190707108243Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
00190707108250Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
00190707108267Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
00190707108274Multi-Adjustable Facemask®ORTHO ORGANIZERS, INC.DZB2025-09-25
10190886051276NAG & H Wire Company, Inc.DZB2025-03-31
10190886051283NAG & H Wire Company, Inc.DZB2025-03-31
10190886051290NAG & H Wire Company, Inc.DZB2025-03-31
10190886051306NAG & H Wire Company, Inc.DZB2025-03-31
10190886051313NAG & H Wire Company, Inc.DZB2025-03-31
10190886051320NAG & H Wire Company, Inc.DZB2025-03-31