FDA.reportPublic FDA data

GuttaSeal ZX® Gutta Percha Points

Primary DI
08800069213395
Brand
GuttaSeal ZX® Gutta Percha Points
Company
SURE DENT CORPORATION
Model
G906 LB15-40/.05
Catalog number
24G906LB154005
Device description
GuttaSeal ZX® Gutta Percha Points, 15-40.05, Slide, 60p, 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
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
08800069213395PrimaryGS10
88800069213391Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800069213395088000692133958800069213395
8880006921339188800069213391

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 in a cool area and avoid exposure to sunlight

Regulatory Flags#

DUNS number
688273010
Device count
60
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
J0030525020Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525025Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525030Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525035Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525040Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525045Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525050Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525055Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525060Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525160Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525165Z1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530F1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FF1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FFZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FM1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FMZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530L1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530M1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530MF1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530MFZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530MZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530XF1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530XFM1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541FL1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541FM1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541FS1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541L1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541M1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541S1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26