EZ-Fill Root Canal Cement 1608-00

GUDID 00766054000143

Root Canal Cement Powder Jar/Gel Tube

ESSENTIAL DENTAL SYSTEMS, INC.

Endodontic filling/sealing material

• Primary Device ID: 00766054000143
• NIH Device Record Key: 0b7922ca-0942-4ee6-bfe8-206cdebcfef7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ-Fill Root Canal Cement
• Version Model Number: 1608-00
• Catalog Number: 1608-00
• 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
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• 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	00766054000143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992727

FDA Product Code

• KIF: RESIN, ROOT CANAL FILLING

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-01

On-Brand Devices [EZ-Fill Root Canal Cement]

• 00766054000143: Root Canal Cement Powder Jar/Gel Tube
• 00766054000136: Root Canal Cement Powder Jar/Gel Tube with Bi-Directional Spirals Nickel Titanium
• 00766054000129: Root Canal Cement Powder Jar/Gel Tube with Bi-Directional Spirals Stainless Steel