Ceramir Crown & Bridge QuikMix

GUDID 17310230102772

Ceramir Crown & Bridge QuikMix Powder 15g

Directa AB

Glass ionomer dental cement

• Primary Device ID: 17310230102772
• NIH Device Record Key: 1a51befe-81f0-49cf-886e-cfc877b29a92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramir Crown & Bridge QuikMix
• Version Model Number: 10277
• Company DUNS: 353954381
• Company Name: Directa AB
• 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: 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: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com
• Phone: +1-800-537 8765
• Email: infousa@directadental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	17310230102772 [Primary]
GS1	17310230400335 [Package]; Package: Box [1 Units]; In Commercial Distribution

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: 2024-04-05
• Device Publish Date: 2024-03-28

On-Brand Devices [Ceramir Crown & Bridge QuikMix]

• 17310230400328: Ceramir Crown & Bridge QuikMix Kit
• 17310230102789: Ceramir Crown & Bridge QuikMix Liquid 10g
• 17310230102772: Ceramir Crown & Bridge QuikMix Powder 15g