FDA.reportPublic FDA data

Prophy Rubber Cup

Primary DI
08806383525893
Brand
Prophy Rubber Cup
Company
DiaDent Group International
Model
Webbed, Snap-on
Catalog number
950-252
Device description
A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning).
Published
2020-08-13
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
08806383525893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806383525893088063835258938806383525893

GMDN Terms#

Term, Definition table
TermDefinition
Dental-professional prophylaxis brush, single-useA non-sterile rotary dental instrument with natural or synthetic bristle brushes intended to be used by a dental hygienist and/or dentist to clean and polish teeth. It is designed to be attached to a powered dental handpiece which provides the necessary rotation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and Keep away from Sunlight.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687789453
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806383591690DIACEM TEMPNEDIACEM TEMPNE 3g(Type S)A2004-69122026-05-13
08806383591706DIACEM TEMPNEDIACEM TEMPNE 10g(Type S)A2004-69132026-05-13
06944835131147DIA-X FILE21mm D1/D4 Asst571-S1912026-02-20
06944835131154DIA-X FILE25mm D1/D4 Asst571-S2912026-02-20
06944835131338DIA-X FILE19mm/21mm DX/D3 Asst571-S1922026-02-20
06944835131345DIA-X FILE19mm/25mm DX/D3 Asst 571-S2912026-02-20
06944835173291DIA-X FILE19mm DX571-S1002026-02-20
06944835173307DIA-X FILE21mm D1 571-S1012026-02-20
06944835173314DIA-X FILE21mm D2 571-S1022026-02-20
06944835173321DIA-X FILE21mm D3571-S1032026-02-20
06944835173338DIA-X FILE21mm D4571-S1042026-02-20
06944835173345DIA-X FILE21mm D5 571-S1052026-02-20
06944835173369DIA-X FILE21mm D6571-S1062026-02-20
06944835173376DIA-X FILE21mm D7 571-S1072026-02-20
06944835173383DIA-X FILE25mm D1571-S2012026-02-20
06944835173390DIA-X FILE25mm D2571-S2022026-02-20
06944835173406DIA-X FILE25mm D3571-S2032026-02-20
06944835173413DIA-X FILE25mm D4571-S2042026-02-20
06944835173420DIA-X FILE25mm D5571-S2052026-02-20
06944835173444DIA-X FILE25mm D6571-S2062026-02-20

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