EDTA

GUDID 00850440008407

17% EDTA Solution

Engineered Endodontics, LLC

Dental tooth-cleaning solution

• Primary Device ID: 00850440008407
• NIH Device Record Key: 7fba02bc-eef9-40df-8104-b3d9b6ad67f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDTA
• Version Model Number: ESEDTA
• 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: true
• Expiration Date: true
• 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	00850440008407 [Primary]

FDA Product Code

• EKQ: Preparer, 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: 2026-01-12
• Device Publish Date: 2026-01-02

Devices Manufactured by Engineered Endodontics, LLC

• 00850440008001 - TUN Ultrasonic Tip: 2026-01-12 TUN Ultrasonic Tip
• 00850440008025 - TUN Ultrasonic Tip: 2026-01-12 TUN Ultrasonic Tip
• 00850440008049 - TUN Ultrasonic Tip: 2026-01-12 TUN Ultrasonic Tip
• 00850440008063 - TUN Ultrasonic Tip: 2026-01-12 TUN Ultrasonic Tip
• 00850440008087 - TUN Ultrasonic Tip: 2026-01-12 TUN Ultrasonic Tip
• 00850440008100 - TUN Ultrasonic Tip: 2026-01-12 TUN Ultrasonic Tip
• 00850440008124 - Finishing File: 2026-01-12 FIle intended to draw irrigation solution to the apex of the root canal to flush the entire canal.
• 00850440008131 - Finishing File: 2026-01-12 File intended to draw irrigation solution to the apex of the root canal to flush the entire canal.