FDA.reportPublic FDA data

Minikut

Primary DI
08800069202788
Brand
Minikut
Company
SURE DENT CORPORATION
Model
P910 L15-40/.05
Catalog number
1680560
Device description
Absorbent Paper Points Taper .05, Size 15-40, 100/PK, mm marked, SB
Published
2022-09-07
Public version status
Update
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
08800069202788PrimaryGS10
88800069202784Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800069202788088000692027888800069202788
8880006920278488800069202784

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809264299005Sure-PasteSure-Paste RK2026-09-28
08809264299104Sure-PrepSure-Prep2026-09-28
08809264299876Sure-Seal RootSSR RK2026-09-28
08800069213814Edge One R GPUS-EORGPAST-12026-06-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941974305163Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-10-30
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