Ceramir BIC QuikCap

GUDID 17310230400373

Ceramir BIC QuikCap Capsule

Directa AB

Glass ionomer dental cement

• Primary Device ID: 17310230400373
• NIH Device Record Key: f15d27e2-5d7e-44c6-9118-d77fd0bfdb31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramir BIC QuikCap
• Version Model Number: 10291
• 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	17310230102918 [Primary]
GS1	17310230400373 [Package]; Contains: 17310230102918; Package: Box [10 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

Devices Manufactured by Directa AB

• 17310230021196 - TrollBag: 2024-07-25
• 17310230021202 - Camera Sleeve: 2024-07-25
• 17310230400304 - Ceramir Crown & Bridge QuikCap: 2024-04-05 Ceramir Crown & Bridge QuikCap Capsule
• 17310230102772 - Ceramir Crown & Bridge QuikMix: 2024-04-05 Ceramir Crown & Bridge QuikMix Powder 15g
• 17310230102789 - Ceramir Crown & Bridge QuikMix: 2024-04-05 Ceramir Crown & Bridge QuikMix Liquid 10g
• 17310230400373 - Ceramir BIC QuikCap: 2024-04-05Ceramir BIC QuikCap Capsule
• 17310230400373 - Ceramir BIC QuikCap: 2024-04-05 Ceramir BIC QuikCap Capsule
• 17310230400328 - Ceramir Crown & Bridge QuikMix: 2024-04-05 Ceramir Crown & Bridge QuikMix Kit
• 17310230021318 - Luxator: 2022-12-15 17310231050416 17310231050423 17310231050430 17310231050447