FDA.reportPublic FDA data

Sure-endo

Primary DI
88809264290503
Brand
Sure-endo
Company
SURE DENT CORPORATION
Model
G906 B10F30.04
Device description
Bio 10F Gutta Percha Points Taper .04, Size 30, 60/PK, SB
Published
2023-06-22
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
EKMGutta-Percha

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809264290507PrimaryGS10
88809264290503Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809264290507088092642905078809264290507
8880926429050388809264290503

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic gutta-perchaA dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature away from direct sunlight

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688273010
Device count
60
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

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Primary DI, Brand, Company table
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