Cavios

GUDID 04560128312561

Cavity Liner

NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.

Dental composite resin

• Primary Device ID: 04560128312561
• NIH Device Record Key: a6fb04cd-aae3-4f73-b84b-5cae8de68817
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cavios
• 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: karin@neodental-intl.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560128312561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111668

FDA Product Code

• EJK: Liner, Cavity, Calcium Hydroxide

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-16

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

• 14560128312629 - Neo Blue Tips: 2021-05-21
• 04560128312530 - Vitapex: 2018-07-06
• 04560128312547 - Vitapex: 2018-07-06
• 04560128312554 - Vitapex: 2018-07-06
• 04560128312561 - Cavios: 2018-07-06Cavity Liner
• 04560128312561 - Cavios: 2018-07-06 Cavity Liner
• 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