FDA.reportPublic FDA data

Gutta Percha Points

Primary DI
D8090525045Z1
Brand
Gutta Percha Points
Company
ROYDENT DENTAL PRODUCTS INC
Model
0525045Z
Catalog number
0525045Z
Device description
Gutta Percha Points GP ISO Cst CCE 45
Published
2022-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
D8090525045Z1PrimaryHIBCC0
D8090525045Z0Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method
Liquid Chemical

Regulatory Flags#

DUNS number
131487225
Device count
120
Premarket exempt
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D80906319015R1Endodontic Hand Instruments06319015R06319015R2022-11-29
D80906319015R0Endodontic Hand Instruments06319015R06319015R2022-11-29
D80906319010R1Endodontic Hand Instruments06319010R06319010R2022-11-10
D80906319010R0Endodontic Hand Instruments06319010R06319010R2022-11-10
D80906319020R1Endodontic Hand Instruments06319020R06319020R2022-11-09
D80906319025R1Endodontic Hand Instruments06319025R06319025R2022-11-09
D80906319160R1Endodontic Hand Instruments06319160R06319160R2022-11-09
D80906321006R1Endodontic Hand Instruments06321006R06321006R2022-11-09
D80906321008R1Endodontic Hand Instruments06321008R06321008R2022-11-09
D80906321010R1Endodontic Hand Instruments06321010R06321010R2022-11-09
D80906321012R1Endodontic Hand Instruments06321012R06321012R2022-11-09
D80906321015R1Endodontic Hand Instruments06321015R06321015R2022-11-09
D80906321017R1Endodontic Hand Instruments06321017R06321017R2022-11-09
D80906321020R1Endodontic Hand Instruments06321020R06321020R2022-11-09
D80906321025R1Endodontic Hand Instruments06321025R06321025R2022-11-09
D80906321030R1Endodontic Hand Instruments06321030R06321030R2022-11-09
D80906321035R1Endodontic Hand Instruments06321035R06321035R2022-11-09
D80906321040R1Endodontic Hand Instruments06321040R06321040R2022-11-09
D80906321045R1Endodontic Hand Instruments06321045R06321045R2022-11-09
D80906321050R1Endodontic Hand Instruments06321050R06321050R2022-11-09

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