Ceramir Crown & Bridge QuikCap

GUDID 17310230400304

Ceramir Crown & Bridge QuikCap Capsule

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: 17310230400304
• NIH Device Record Key: 33980864-cf55-4c18-b9a9-c5a18780d556
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramir Crown & Bridge QuikCap
• Version Model Number: 10257
• 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	17310230102574 [Primary]
GS1	17310230400298 [Package]; Contains: 17310230102574; Package: Box [5 Units]; In Commercial Distribution
GS1	17310230400304 [Package]; Contains: 17310230102574; Package: Box [20 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

• 17310230400304 - Ceramir Crown & Bridge QuikCap: 2024-04-05Ceramir Crown & Bridge QuikCap Capsule
• 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: 2024-04-05 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
• 17310230021325 - Luxator: 2022-12-15 17310231050461 17310231050430 17310231050416 17310231050454 17310231050478 17310231050447 17310231050423
• 17310230021332 - Luxator: 2022-12-15 17310231050485 17310231050461 17310231050430 17310231050416 17310231050454