FDA.reportPublic FDA data

Multi-Adjustable Facemask

Primary DI
00190730002617
Brand
Multi-Adjustable Facemask
Company
ORTHO TECHNOLOGY, INC.
Model
550-404
Device description
Multi-Adj Facemask Pearl
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00190730002617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190730002617001907300026171907300026170190730002617

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic extraoral headgearA dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
781772017
Device count
1
DM exempt
true
Premarket exempt
false
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
10190730084535Clear Advantage7500-1002025-07-24
10190730084542Clear Advantage7500-1052025-07-24
10190730084559Clear Advantage7500-1102025-07-24
10190730084566Clear Advantage7500-0352025-07-24
10190730084573Clear Advantage7500-0402025-07-24
10190730084580Sports Advantage7500-1652025-07-24
10190730084597Sports Advantage7500-1402025-07-24
00190730084682Ortho TechnologyOT-000-SS2024-09-18
00190730084811Ortho TechnologyOT-000-SS-D2024-09-18
00190730084828Ortho TechnologyOT-2118-SS2024-09-18
00190730084835Ortho TechnologyOT-2118-SSD2024-09-18
00190730084842Ortho TechnologyOT-2122-SS2024-09-18
00190730084859Ortho TechnologyOT-2122-SSD2024-09-18
00190730084354Ortho TechnologyOT-0272024-09-17
00190730084361Ortho TechnologyOT-0282024-09-17
00190730084378Ortho TechnologyOT-2032024-09-17
00190730084385Ortho TechnologyOT-2042024-09-17
00190730084392Ortho TechnologyOT-2062024-09-17
00190730084439Ortho TechnologyOT-2092024-09-17
00190730084507Ortho TechnologyOT-209R2024-09-17

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