FDA.reportPublic FDA data

Sure-endo

Primary DI
88809264290589
Brand
Sure-endo
Company
SURE DENT CORPORATION
Model
G906 B10F20.06
Device description
Bio 10F Gutta Percha Points Taper .06, Size 20, 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
08809264290583PrimaryGS10
88809264290589Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809264290583088092642905838809264290583
8880926429058988809264290589

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
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
08800069213302GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213319GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213326GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213333GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213340GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213357GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213364GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213371GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213388GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213395GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213401GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213418GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213425GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213432GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213449GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213456GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213104Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213111Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213128Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213135Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069204775B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204782B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204799B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069205000B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204805XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204812XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204829XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204836XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204843XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204669MinikutSURE DENT CORPORATIONEKM2023-09-06