Ceramir Bioceramic Implant Cement QuikCap 40037

GUDID 07350052430298

Doxa Dental AB

Glass ionomer dental cement

• Primary Device ID: 07350052430298
• NIH Device Record Key: 441eb0ee-a251-4725-a0cf-708edf0181de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramir Bioceramic Implant Cement QuikCap
• Version Model Number: 40037
• Catalog Number: 40037
• Company DUNS: 350486340
• Company Name: Doxa Dental AB
• Device Count: 10
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350052430298 [Primary]
GS1	07350052430304 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113040

FDA Product Code

• EMA: Cement, Dental

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: 2019-03-28
• Device Publish Date: 2019-03-20

Devices Manufactured by Doxa Dental AB

• 07350052430182 - Ceramir Applicator 2: 2023-06-16
• 07350052430380 - Ceramir® Protect LC Syringe: 2021-07-19
• 07350052430403 - Ceramir® Protect LC Syringe: 2021-07-19
• 07350052430311 - Ceramir® Restore QuikCap: 2021-01-08
• 07350052430298 - Ceramir Bioceramic Implant Cement QuikCap: 2019-03-28
• 07350052430298 - Ceramir Bioceramic Implant Cement QuikCap: 2019-03-28
• 07350052430151 - Ceramir Crown & Bridge QuikCap: 2018-09-17
• 07350052430168 - Ceramir Crown & Bridge QuikCap: 2018-09-17
• 07350052430175 - Ceramir Crown & Bridge QuikCap: 2018-09-17