FDA.reportPublic FDA data

The Orthodontic Store

Primary DI
00840326411001
Brand
The Orthodontic Store
Company
Young Innovations, Inc.
Model
187-015
Catalog number
187-015
Device description
Push On Non Latex Prophy Cups
Published
2022-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHKCUP, PROPHYLAXIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHKCup, ProphylaxisDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840326411008PackageGS1144In Commercial Distribution
00840326411001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084032641100810840326411008
00840326411001008403264110018403264110010840326411001

GMDN Terms#

Term, Definition table
TermDefinition
Dental polishing cup, reusableA rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a reusable 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
No natural rubber latex
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
07897990300103PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300110PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300127PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300219PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300233PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300264PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300271PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300288PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300295PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300325PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300332PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301070PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301087PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301094PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301100PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301117PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301124PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301131PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301148PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990399985PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990399992PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
D2486058701Hager Prophy Brush Fine FlatHAGER WORLDWIDE, INC.EHK2026-05-12
D2486058711Hager Prophy Brush Regular FlatHAGER WORLDWIDE, INC.EHK2026-05-12
TQ26PA25523S1Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHK2024-10-31
TQ26PA25525F1Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHK2024-10-31
00302730003246Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003253Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003260Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003277Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
D686200327713Waterpik Professional Dental Products Sample PackWATER PIK, INC.EHK2023-08-24