FDA.reportPublic FDA data

Prophy Rubber Cup

Primary DI
08806383525855
Brand
Prophy Rubber Cup
Company
DiaDent Group International
Model
Umbrella Shape, Latch Type
Catalog number
950-231
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
OTC
false
Sterile
false
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
08806383525855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806383525855088063835258558806383525855

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06944835173451DIA-X FILE25mm D7571-S2072026-02-20
08806383564687Diapex PlusType AA1001-5012019-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850079280366CavexHexa DentalEHK2026-01-22
00850079280373CavexHexa DentalEHK2026-01-22
00850079280380CavexHexa DentalEHK2026-01-22
00883205032638OpalCupsULTRADENT PRODUCTS, INC.EHK2025-03-11
06975492100023PBCDONGGUAN YILONG MEDICAL SUPPLIES CO.. LTD.EHK2025-01-09
TQ26PA25523S0Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHK2024-10-31
TQ26PA25525F0Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHK2024-10-31
10302730003243Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
10302730003250Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
10302730003267Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
10302730003274Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003284Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003291Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00842517111578Karl SchumacherKarl Schumacher Dental, LLCEHK2024-03-01
00842517103214Karl SchumacherKarl Schumacher Dental, LLCEHK2024-02-27
00842517103221Karl SchumacherKarl Schumacher Dental, LLCEHK2024-02-27
00348783001181ProFlarePREMIER DENTAL PRODUCTS COMPANYEHK2023-10-26
00348783004564ProFlarePREMIER DENTAL PRODUCTS COMPANYEHK2023-10-26
00813360023424AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023431AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023448AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023455AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023462AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023479AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023486AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023493AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023509AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023516AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023523AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023530AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25