Ceramir® Protect LC Syringe 40044

GUDID 07350052430380

Doxa Dental AB

Dental composite resin

• Primary Device ID: 07350052430380
• NIH Device Record Key: 3e9e70e7-3734-42e7-bcb6-9e115d3b3b06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramir® Protect LC Syringe
• Version Model Number: 40044
• Catalog Number: 40044
• Company DUNS: 350486340
• Company Name: Doxa Dental AB
• Device Count: 4
• 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: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com
• Phone: 1.855.369-2872
• Email: info@CeramirUS.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350052430380 [Unit of Use]
GS1	07350052430397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202413

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: 1
• Public Version Date: 2021-07-19
• Device Publish Date: 2021-07-11

On-Brand Devices [Ceramir® Protect LC Syringe]

• 07350052430403: 40045
• 07350052430380: 40044