FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040099551
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
2020345
Catalog number
2020345
Device description
Channels Paper Points
Published
2019-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EKNPOINT, PAPER, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKNPoint, Paper, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040099551PrimaryGS10
H65820203451SecondaryHIBCC0
10304040099558Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040099551003040400995513040400995510304040099551
1030404009955810304040099558

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic paper pointA non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device.

Regulatory Flags#

DUNS number
012430880
Device count
100
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040200589Henry Schein570609457060942026-10-06
10304040193843Henry Schein570560657056062026-10-05
10304040193850Henry Schein570560757056072026-10-05
10304040193867Henry Schein570560857056082026-10-05
10304040193874Henry Schein570560957056092026-10-05
10304040193881Henry Schein570561057056102026-10-05
10304040193898Henry Schein570561157056112026-10-05
10304040194109Henry Schein570562257056222026-10-05
10304040194116Henry Schein570562357056232026-10-05
10304040194208Henry Schein570569757056972026-10-05
10304040194215Henry Schein570569857056982026-10-05
10304040194222Henry Schein570569957056992026-10-05
10304040194239Henry Schein570570057057002026-10-05
10304040194246Henry Schein570570157057012026-10-05
10304040194253Henry Schein570570257057022026-10-05
10304040194260Henry Schein570570357057032026-10-05
10304040194277Henry Schein570570457057042026-10-05
10304040194284Henry Schein570570557057052026-10-05
10304040194291Henry Schein570570657057062026-10-05
10304040194307Henry Schein570570757057072026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941974305156Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974305170Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974305200Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974308461Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974308577Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974309277Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974316343Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974319764Gutta Percha Points Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
08800069213463Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213470Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213487Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213494Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213500Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213517Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213524Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213531Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213548Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213555Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213562Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213579Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213586Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213593Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213609Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213616Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213142Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213159Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213166Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213173Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069204850XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204867XP-4DSURE DENT CORPORATIONEKN2025-01-07