FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040165826
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703192
Catalog number
5703192
Device description
Acclean DPA Snap On Soft Rdge, gray, 100/Bx
Published
2022-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00304040165829PrimaryGS10
10304040165826Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040165829003040401658293040401658290304040165829
1030404016582610304040165826

GMDN Terms#

Term, Definition table
TermDefinition
Dental polishing cup, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
100
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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