EZ-Fill Xpress 1620-00

GUDID 00766054000167

Root Canal Xpress Cement Syringeable with Bi-Directional Spirals Stainless Steel

ESSENTIAL DENTAL SYSTEMS, INC.

Endodontic filling/sealing material

• Primary Device ID: 00766054000167
• NIH Device Record Key: 411dd56a-6cd9-4490-9a65-48ec48ec844e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ-Fill Xpress
• Version Model Number: 1620-00
• Catalog Number: 1620-00
• 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: true
• 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	00766054000167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063856

FDA Product Code

• KIF: RESIN, ROOT CANAL FILLING

Sterilization

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

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

[00766054000167]

Moist Heat or Steam Sterilization

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 Xpress]

• 00766054000174: Root Canal Xpress Cement Syringeable with Bi-Directional Spirals Nickel Titanium
• 00766054000167: Root Canal Xpress Cement Syringeable with Bi-Directional Spirals Stainless Steel