Finishing File

GUDID 00850440008148

File intended to draw irrigation solution to the apex of the root canal to flush the entire canal.

Engineered Endodontics, LLC

Endodontic lavage system

• Primary Device ID: 00850440008148
• NIH Device Record Key: 21999c74-2abc-47b6-871e-c55da25b2327
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Finishing File
• Version Model Number: 200431
• Company DUNS: 079892178
• Company Name: Engineered Endodontics, LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850440008148 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

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

[00850440008148]

Moist Heat or Steam Sterilization

[00850440008148]

Moist Heat or Steam Sterilization

[00850440008148]

Moist Heat or Steam Sterilization

[00850440008148]

Moist Heat or Steam Sterilization

[00850440008148]

Moist Heat or Steam Sterilization

[00850440008148]

Moist Heat or Steam Sterilization

[00850440008148]

Moist Heat or Steam Sterilization

[00850440008148]

Moist Heat or Steam Sterilization

[00850440008148]

Moist Heat or Steam Sterilization

[00850440008148]

Moist Heat or Steam Sterilization

[00850440008148]

Moist Heat or Steam Sterilization

[00850440008148]

Moist Heat or Steam Sterilization

[00850440008148]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-12
• Device Publish Date: 2026-01-02

On-Brand Devices [Finishing File]

• 00850440008148: File intended to draw irrigation solution to the apex of the root canal to flush the entire cana
• 00850440008131: File intended to draw irrigation solution to the apex of the root canal to flush the entire cana
• 00850440008124: FIle intended to draw irrigation solution to the apex of the root canal to flush the entire cana