FDA.reportPublic FDA data

Young Specialties

Primary DI
00843471151273
Brand
Young Specialties
Company
Young Innovations, Inc.
Model
399-035
Catalog number
399-035
Device description
Aligner Seater, WHITE un-scented
Published
2024-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
10843471151270PackageGS110In Commercial Distribution
00843471151273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084347115127010843471151270
00843471151273008434711512738434711512730843471151273

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.

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
Expiration 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
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
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
10889950083410Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCECS2023-06-27