EVADYNE TEMPORARY CROWN AND BRIDGE RESIN

GUDID 04560128312578

Temporary Crown and Bridge Resin

NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.

Dental crown/bridge resin, temporary

• Primary Device ID: 04560128312578
• NIH Device Record Key: 131a186c-8482-4724-b1ca-28f96ca27ec2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVADYNE TEMPORARY CROWN AND BRIDGE RESIN
• Version Model Number: ―
• Company DUNS: 691229181
• Company Name: NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.
• Device Count: 1
• DM Exempt: false
• 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: false
• 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: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com
• Phone: 253-946-0814
• Email: ndi@neodental-intl.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560128312578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111666

FDA Product Code

• EBG: Crown And Bridge, Temporary, 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: 2017-11-07

Devices Manufactured by NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.

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• 04560128312547 - Vitapex: 2018-07-06
• 04560128312554 - Vitapex: 2018-07-06
• 04560128312561 - Cavios: 2018-07-06 Cavity Liner
• 04560128312578 - EVADYNE TEMPORARY CROWN AND BRIDGE RESIN: 2018-07-06Temporary Crown and Bridge Resin
• 04560128312578 - EVADYNE TEMPORARY CROWN AND BRIDGE RESIN: 2018-07-06 Temporary Crown and Bridge Resin
• 04560128312585 - Dentalis: 2018-07-06 Endodontic sealing material, 15g Powder, 10mL Liquid
• 04560128312592 - Dentalis: 2018-07-06 Endodontic sealing material, 15g Powder