FDA.reportPublic FDA data

Absorbent Paper Points

Primary DI
08800069213524
Brand
Absorbent Paper Points
Company
SURE DENT CORPORATION
Model
P910 L40.03
Catalog number
24P910 L4003
Device description
Absorbent Paper Points, 40.03, Slide, 100p, Length marked
Published
2026-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
08800069213524PrimaryGS10
88800069213520Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800069213524088000692135248800069213524
8880006921352088800069213520

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature.

Regulatory Flags#

DUNS number
688273010
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800069213302GuttaSeal ZX® Gutta Percha PointsG906 LB15.0324G906LB15032026-02-09
08800069213319GuttaSeal ZX® Gutta Percha PointsG906 LB15-40/.0324G906LB1540032026-02-09
08800069213326GuttaSeal ZX® Gutta Percha PointsG906 LB20.0324G906LB20032026-02-09
08800069213333GuttaSeal ZX® Gutta Percha PointsG906 LB25.0324G906LB25032026-02-09
08800069213340GuttaSeal ZX® Gutta Percha PointsG906 LB30.0324G906LB30032026-02-09
08800069213357GuttaSeal ZX® Gutta Percha PointsG906 LB35.0324G906LB35032026-02-09
08800069213364GuttaSeal ZX® Gutta Percha PointsG906 LB40.0324G906LB40032026-02-09
08800069213371GuttaSeal ZX® Gutta Percha PointsG906 LB45.0324G906LB45032026-02-09
08800069213388GuttaSeal ZX® Gutta Percha PointsG906 LB15.0524G906LB15052026-02-09
08800069213395GuttaSeal ZX® Gutta Percha PointsG906 LB15-40/.0524G906LB1540052026-02-09
08800069213401GuttaSeal ZX® Gutta Percha PointsG906 LB20.0524G906LB20052026-02-09
08800069213418GuttaSeal ZX® Gutta Percha PointsG906 LB25.0524G906LB25052026-02-09
08800069213425GuttaSeal ZX® Gutta Percha PointsG906 LB30.0524G906LB30052026-02-09
08800069213432GuttaSeal ZX® Gutta Percha PointsG906 LB35.0524G906LB35052026-02-09
08800069213449GuttaSeal ZX® Gutta Percha PointsG906 LB40.0524G906LB40052026-02-09
08800069213456GuttaSeal ZX® Gutta Percha PointsG906 LB45.0524G906LB45052026-02-09
08800069213463Absorbent Paper PointsP910 L15.0324P910L15032026-02-09
08800069213470Absorbent Paper PointsP910 L15-40/.0324P910L1540032026-02-09
08800069213487Absorbent Paper PointsP910 L20.0324P910L20032026-02-09
08800069213494Absorbent Paper PointsP910 L25.0324P910L25032026-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
08800069204874XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204881XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204898XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069209497Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16
08800069209503Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16
08800069209510Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16
08800069209527Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16
08800069209534Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16
08800069209541Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16