FDA.reportPublic FDA data

2Pro

Primary DI
D6915500999
Brand
2Pro
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
5500999
Device description
2pro Disposable Prophy Angle Sample 1
Published
2022-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
D6915500999PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014789663
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783011135Premier Decann Stopper10378162026-05-27
00348783011920Poli-Pro Disks20190992026-05-27
00348783011975Poli-Pro Disks20190752026-05-27
00348783011982Poli-Pro Disks20190762026-05-27
00348783011999Poli-Pro Disks20190772026-05-27
00348783012019Poli-Pro Disks20190792026-05-27
00348783011913Poli-Pro Disks20190702026-05-26
00348783011937Poli-Pro Disks20190712026-05-26
00348783011951Poli-Pro Disks20190732026-05-26
00348783006919Premier Scalers056332026-05-06
00348783006971Premier Scalers056922026-05-06
00348783006988Premier Scalers056942026-05-06
00348783006995Premier Scalers056952026-05-06
00348783007251Premier Scalers90614002026-05-06
00348783007268Premier Scalers90614012026-05-06
00348783007275Premier Scalers90614022026-05-06
00348783007299Premier Scalers90614202026-05-06
00348783007329Premier Scalers90614232026-05-06
00348783007374Premier Scalers10046862026-05-06
00348783007398Premier Scalers10046882026-05-06

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