FDA.reportPublic FDA data

Gutta Percha Points

Primary DI
D8090530FMZ1
Brand
Gutta Percha Points
Company
ROYDENT DENTAL PRODUCTS INC
Model
0530FMZ
Catalog number
0530FMZ
Device description
Gutta Percha Points Size Size: Fine-Medium
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
D8090530FMZ1PrimaryHIBCC0
D8090530FMZ0Unit 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