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
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190746059230Acid Etchant020-028535020-0285352022-10-05
00190746059247Acid Etchant020-028536020-0285362022-10-05
00190746062896BracePaste Fluoride Sealant Kit020-039668020-0396682024-10-28
00190746188800BracePaste Fluoride Sealant020-035993020-0359932024-10-10
00190746059193BracePaste020-026877020-0268772022-10-05
00190746059209BracePaste020-026878020-0268782022-10-05
00190746059216BracePaste020-026879020-0268792022-10-05
00190746059223BracePaste020-026880020-0268802022-10-05
00190746059254BracePaste MTP Light Cure Primer020-029614020-0296142022-10-05
00190746059261BracePaste MTP Kit020-030089020-0300892022-10-05
00190746059285BracePaste020-031573020-0315732022-10-05
00190746059292BracePaste020-031574020-0315742022-10-05
00190746059322BracePaste020-031575020-0315752022-10-05
00190746059339Bracepaste Band and Build LC020-032026020-0320262022-10-05
00190746059346Bracepaste Band and Build LC020-032027020-0320272022-10-05
00190746059476Carbide BurFG118LFG118L2022-10-05
00190746059506Carbide BurFG118SFG118S2022-10-05
00190746059513Carbide BurFG218FG2182022-10-05
00190746059520Carbide BurFG283-014FG283-0142022-10-05
00190746059551Diamond BurFG392-016FFG392-016F2022-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10190886051917NAG & H Wire Company, Inc.DZB2025-03-31
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10190886052020NAG & H Wire Company, Inc.DZB2025-03-31
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10190886052068NAG & H Wire Company, Inc.DZB2025-03-31
10190886052075NAG & H Wire Company, Inc.DZB2025-03-31
10190886155226NAG & H Wire Company, Inc.DZB2025-03-31
10190886155233NAG & H Wire Company, Inc.DZB2025-03-31
10190886155240NAG & H Wire Company, Inc.DZB2025-03-31
10190886155257NAG & H Wire Company, Inc.DZB2025-03-31
10190886155264NAG & H Wire Company, Inc.DZB2025-03-31
10195291008266N/AFlexmedicsDZB2020-05-26
10195291009133N/AFlexmedicsDZB2020-05-26
10195291009140N/AFlexmedicsDZB2020-05-26
10195291009157N/AFlexmedicsDZB2020-05-26
10195291009164N/AFlexmedicsDZB2020-05-26