EZ-Fill Xpress Cement 1628-00

GUDID 00766054000181

Root Canal Xpress Cement Syringeable

ESSENTIAL DENTAL SYSTEMS, INC.

Endodontic filling/sealing material Endodontic filling/sealing material Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement

• Primary Device ID: 00766054000181
• NIH Device Record Key: c1874011-48da-49ee-b829-f1c65e653062
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ-Fill Xpress Cement
• Version Model Number: 1628-00
• Catalog Number: 1628-00
• 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	00766054000181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063856

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

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