FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040165871
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703167
Catalog number
5703167
Device description
Acclean DPA Screw Soft Ridge, Gray, 100 ct
Published
2022-10-25
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
EGSHandpiece, contra- and right-angle attachment, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040165874PrimaryGS10
10304040165871Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040165874003040401658743040401658740304040165874
1030404016587110304040165871

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
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
20686864060943MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
20686864060950MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
00850079280069Turbo EdgeHexa DentalEGS2026-01-21
00850079280083Turbo edgeHexa DentalEGS2026-01-21
00008579280083Turbo edgeHexa DentalEGS2026-01-21
00085007928069Turbo EdgeHexa DentalEGS2026-01-21
00850079280076Turbo EdgeHexa DentalEGS2026-01-21
00850079280090Turbo EdgeHexa DentalEGS2026-01-21
00850079280106Turbo EdgeHexa DentalEGS2026-01-21
00850079280113Ergo glideHexa DentalEGS2026-01-21
08404535020892Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020922Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020953Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020984Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535021738ForzaPeter Brasseler Holdings, LLCEGS2026-01-09
00304040194331Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194348Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194355Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194362Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194379Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194386Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
D745701120GLH00010Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D745701120GLH00020Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D745701120GLH00030Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D950135030SmoothdriveLARES RESEARCHEGS2025-08-25
06971119540548Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540586Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540593Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540982Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540999Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15