Irritrol 760-16

GUDID 00766054000105

Two-In-One Endodontic Irrigation Liquid for Cleansing a Root Canal

ESSENTIAL DENTAL SYSTEMS, INC.

Root canal cleaning solution

• Primary Device ID: 00766054000105
• NIH Device Record Key: 264bf428-938e-47dc-ad13-afee24c287d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irritrol
• Version Model Number: 760-16
• Catalog Number: 760-16
• Company DUNS: 101147171
• Company Name: ESSENTIAL DENTAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com

Device Dimensions

• Total Volume: 16 Fluid Ounce
• Total Volume: 16 Fluid Ounce
• Total Volume: 16 Fluid Ounce
• Total Volume: 16 Fluid Ounce

Operating and Storage Conditions

• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00766054000105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150020

FDA Product Code

• KJJ: CLEANSER, ROOT CANAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-07-01

Devices Manufactured by ESSENTIAL DENTAL SYSTEMS, INC.

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• 00766054003007 - Turbo-CR: 2025-04-14 Disposable Fluoride Trays
• 00766054002949 - BIOSEAL: 2024-11-08 Bioceramic Endodontic Sealer
• 00766054002970 - BIOSEAL: 2024-11-08 EndoTips
• 00766054002901 - Bio-LCB: 2022-11-07 Light Cured Base and Liner Syrinageable
• 00766054002918 - Bio-LCB: 2022-11-07 Light Cured Base and Liner Syrinageable
• 00766054002925 - Bio-LCB: 2022-11-07 50 Light Cured Base and Liner Syringe Tips