FDA.reportPublic FDA data

The Orthodontic Store

Primary DI
00843471137659
Brand
The Orthodontic Store
Company
Young Innovations, Inc.
Model
386-800
Catalog number
386-800
Device description
Direct Bond Lingual Button, Flat
Published
2022-11-01
Public version status
New
Distribution status
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
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843471137656PackageGS110In Commercial Distribution
00843471137659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084347113765610843471137656
00843471137659008434711376598434711376590843471137659

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic power armA dental device in the shape of a straight pin or hook designed to accept an elastic band, power chain, spring, or archwire (not included), which apply a force in addition to the main orthodontic archwire, for vertical alignment and/or horizontal positioning of the teeth; it may include a base that functions as an orthodontic lock/stop. The device is typically crimped, soldered, screwed on, or inserted in the slot of an orthodontic attachment (e.g., bracket, band), or on the surface of a tooth for orthodontic traction. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 558-6684support@youngspecialties.com

Regulatory Flags#

DUNS number
004193103
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
00840326426630Astek1002991002992026-05-11
00840326423851Astek19025190252025-03-17
00840326423868Astek19026190262025-03-17
00840326423875Astek19027190272025-03-17
00840326423882Astek19028190282025-03-17
00843471150061Astek19000190002022-10-18
00843471150078Astek19005190052022-10-18
00843471150085Astek19001190012022-10-18
00843471150092Astek19006190062022-10-18
00840326426586Plak Smacker2000622026-04-20
00840326426593Plak Smacker2000632026-04-20
00840326426609Plak Smacker2000642026-04-20
00840326426616Plak Smacker2000652026-04-20
00840326426623Plak Smacker2000662026-04-20
00840326426203Young Specialties2000-02-102000-02-102026-01-26
00840326426210Young Specialties2000-03-102000-03-102026-01-26
00840326426227Young Specialties2000-04-102000-04-102026-01-26
00840326426234Young Specialties2000-05-102000-05-102026-01-26
00840326426241Young Specialties2000-06-102000-06-102026-01-26
00840326426258Young Specialties2000-07-102000-07-102026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190707192976Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192983Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192990Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193003Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193010Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193027Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193034Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193041Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193058Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193065Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193072Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193089Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193096Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193102Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193119Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193126Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
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00190746141461Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141515Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141522Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746175442Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746175459Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746161575Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746174957Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175268Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175275Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175503Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175510Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26