FDA.reportPublic FDA data

Elements Gutta Percha Cartridge 10 PCS

Primary DI
08809455601723
Brand
Elements Gutta Percha Cartridge 10 PCS
Company
META SYSTEMS CO., LTD.
Model
Gutta Percha, Medium body, 23 Gauge
Catalog number
972-2500
Device description
The Elements™ Gutta Percha Cartridge (The Gutta Percha Cartridge) is a device that contains gutta-percha material. It is used in conjunction with the Backfill Unit of elements™ IC obturation device or with the Extruder Handpiece of the elements Obturation Unit™. The gutta-percha material is heated and extruded from the cartridge to obturate the root canal as part of an endodontic treatment procedure. The Gutta Percha Cartridge is available in Light 25 gauge, and Medium, Heavy body in 23 gauge.
Published
2024-12-30
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
08809455601723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809455601723088094556017238809455601723

GMDN Terms#

Term, Definition table
TermDefinition
Natural gutta-perchaA dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687503532
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809455602829LHALA JETMA-9410A2026-04-23
08809455602515Demi Pro37371373712026-04-22
08809455602522Demi Pro37372373722026-04-22
08809455602539Demi Pro37373373732026-04-22
08809455602546Demi Pro37374373742026-04-22
08809455602553Demi Pro37375373752026-04-22
08809455602560Demi Pro37376373762026-04-22
08809455602508Demi Pro37370373702026-04-21
08809455602577Demi Pro37377373772026-04-21
08809455602072Apex IDApex ID Kit972-00902024-12-30
08809455602089Apex IDApex ID Main Body972-00852024-12-30
08809455602096Apex ID Apex ID Lip Hook (5 PCS)972-00922024-12-30
08809455602102Apex IDApex ID File Holder B (2 PCS)972-00932024-12-30
08809455602119Apex IDApex ID File Holder A972-00942024-12-30
08809455602126Apex IDApex ID Probe Cord 972-00952024-12-30
08809455602683elements Connect815-18302025-06-05
08809455602720elements Connect815-18312025-06-05
08809455602744elements Connect815-18102025-06-05
08809455602768Apex Connect815-18172025-06-05
08809455601730Elements Gutta Percha Cartridge 10 PCSGutta Percha, Light body 25 Gauge972-25012024-12-30

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