FDA.reportPublic FDA data

F360

Primary DI
88809264297991
Brand
F360
Company
SURE DENT CORPORATION
Model
PPSF04
Device description
Absorbent Paper Points Taper .04, Size 25,35,45,55, 200/PK, mm marked, CP, 25,35,45,55/.04
Published
2022-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
18809264297992PrimaryGS10
88809264297991Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1880926429799218809264297992
8880926429799188809264297991

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688273010
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
88800069213308GuttaSeal ZX® Gutta Percha PointsG906 LB15.0324G906LB15032026-02-09
88800069213315GuttaSeal ZX® Gutta Percha PointsG906 LB15-40/.0324G906LB1540032026-02-09
88800069213322GuttaSeal ZX® Gutta Percha PointsG906 LB20.0324G906LB20032026-02-09
88800069213339GuttaSeal ZX® Gutta Percha PointsG906 LB25.0324G906LB25032026-02-09
88800069213346GuttaSeal ZX® Gutta Percha PointsG906 LB30.0324G906LB30032026-02-09
88800069213353GuttaSeal ZX® Gutta Percha PointsG906 LB35.0324G906LB35032026-02-09
88800069213360GuttaSeal ZX® Gutta Percha PointsG906 LB40.0324G906LB40032026-02-09
88800069213377GuttaSeal ZX® Gutta Percha PointsG906 LB45.0324G906LB45032026-02-09
88800069213384GuttaSeal ZX® Gutta Percha PointsG906 LB15.0524G906LB15052026-02-09
88800069213391GuttaSeal ZX® Gutta Percha PointsG906 LB15-40/.0524G906LB1540052026-02-09
88800069213407GuttaSeal ZX® Gutta Percha PointsG906 LB20.0524G906LB20052026-02-09
88800069213414GuttaSeal ZX® Gutta Percha PointsG906 LB25.0524G906LB25052026-02-09
88800069213421GuttaSeal ZX® Gutta Percha PointsG906 LB30.0524G906LB30052026-02-09
88800069213438GuttaSeal ZX® Gutta Percha PointsG906 LB35.0524G906LB35052026-02-09
88800069213445GuttaSeal ZX® Gutta Percha PointsG906 LB40.0524G906LB40052026-02-09
88800069213452GuttaSeal ZX® Gutta Percha PointsG906 LB45.0524G906LB45052026-02-09
88800069213469Absorbent Paper PointsP910 L15.0324P910L15032026-02-09
88800069213476Absorbent Paper PointsP910 L15-40/.0324P910L1540032026-02-09
88800069213483Absorbent Paper PointsP910 L20.0324P910L20032026-02-09
88800069213490Absorbent Paper PointsP910 L25.0324P910L25032026-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978880220006ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220013ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220020ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220037ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220044ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
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06978880220068ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220075ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220082ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220099ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220105ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220112ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
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06978880220136ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220143ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220150ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220167ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220174ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220181ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220198ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220204ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220211ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220228ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220235ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220242ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220259ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220266ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220273ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220280ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220297ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09