EDS Self Etch Bonding Agent 900-00

GUDID 00766054000341

Self Etch Bonding Agent

ESSENTIAL DENTAL SYSTEMS, INC.

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• Primary Device ID: 00766054000341
• NIH Device Record Key: 09e1449a-13ad-4622-9c40-8391d5e45695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDS Self Etch Bonding Agent
• Version Model Number: 900-00
• Catalog Number: 900-00
• 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

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00766054000341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984503

FDA Product Code

• KLE: AGENT, TOOTH BONDING, RESIN

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: 2017-02-01

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