Ceramir Crown & Bridge QuikMix

GUDID 17310230102789

Ceramir Crown & Bridge QuikMix Liquid 10g

Directa AB

Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement

• Primary Device ID: 17310230102789
• NIH Device Record Key: 87c76d4f-7dd1-4715-90b2-0cc7cd6604f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramir Crown & Bridge QuikMix
• Version Model Number: 10278
• 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	17310230102789 [Primary]
GS1	17310230400342 [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