FDA.reportPublic FDA data

2PRO

Primary DI
00348783004458
Brand
2PRO
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
5510004
Device description
2PRO BULK PK-Firm/Long/Green-1000
Published
2022-06-29
Public version status
Update
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
00348783004427PackageGS11000In Commercial Distribution
00348783004458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783004427003487830044273487830044270348783004427
00348783004458003487830044583487830044580348783004458

GMDN Terms#

Term, Definition table
TermDefinition
DentifriceA substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014789663
Device count
1000
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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