elements IC 973-0630

GUDID 08809455602164

The cordless elements IC obturation system combines a Downpack heat source with a Backfill extruder. The Downpack device provides fast heating of the heat plugger with precisely controlled temperature and timing, making it suitable for single-motion downpack obturation of the apical portion of the root canal. Utilizing single-use gutta-percha cartridges, the ergonomic Backfill device has a motorized extruder system for precise temperature and speed control for a 3-dimensional obturation of the root canal system.

META SYSTEMS CO., LTD.

Endodontic obturation system

• Primary Device ID: 08809455602164
• NIH Device Record Key: 2f5367d1-70f5-4529-ac99-90274819d436
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: elements IC
• Version Model Number: Backfill
• Catalog Number: 973-0630
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	08809455602164 [Primary]

FDA Product Code

• EKR: Plugger, Root Canal, Endodontic

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 IC ]

• 08809455602409: The cordless elements IC obturation system combines a Downpack heat source with a Backfill extru
• 08809455602393: The cordless elements IC obturation system combines a Downpack heat source with a Backfill extru
• 08809455602386: The cordless elements IC obturation system combines a Downpack heat source with a Backfill extru
• 08809455602195: The cordless elements IC obturation system combines a Downpack heat source with a Backfill extru
• 08809455602188: The cordless elements IC obturation system combines a Downpack heat source with a Backfill extru
• 08809455602171: The cordless elements IC obturation system combines a Downpack heat source with a Backfill extru
• 08809455602164: The cordless elements IC obturation system combines a Downpack heat source with a Backfill extru