Elements Gutta Percha Cartridge 10 PCS 972-2502

GUDID 08809455601747

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.

META SYSTEMS CO., LTD.

Natural gutta-percha

• Primary Device ID: 08809455601747
• NIH Device Record Key: e7272273-8f3c-46c8-a09c-31f8af587a4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elements Gutta Percha Cartridge 10 PCS
• Version Model Number: Gutta Percha, Heavy body, 23 Gauge
• Catalog Number: 972-2502
• Company DUNS: 687503532
• Company Name: META SYSTEMS CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809455601747 [Primary]

FDA Product Code

• EKM: Gutta-Percha

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-07
• Device Publish Date: 2024-12-30

On-Brand Devices [Elements Gutta Percha Cartridge 10 PCS]

• 08809455601747: The Elements™ Gutta Percha Cartridge (The Gutta Percha Cartridge) is a device that contains gu
• 08809455601730: The Elements™ Gutta Percha Cartridge (The Gutta Percha Cartridge) is a device that contains gu
• 08809455601723: The Elements™ Gutta Percha Cartridge (The Gutta Percha Cartridge) is a device that contains gu