NuSmile BioFlx Anterior Central and Lateral - Mini Kit

GUDID 00810118105524

NuSmile BioFlx Anterior Central and Lateral - Mini Kit - 20 Crowns

NUSMILE, LTD.

Preformed dental crown, temporary

• Primary Device ID: 00810118105524
• NIH Device Record Key: 509d4087-2ccb-4f79-9ae9-e3dcef43d3e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuSmile BioFlx Anterior Central and Lateral - Mini Kit
• Version Model Number: MN404C
• Company DUNS: 185497372
• Company Name: NUSMILE, LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com
• Phone: 7138610033
• Email: smunoz@nusmile.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810118105524 [Primary]

FDA Product Code

• ELZ: Crown, Preformed

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: 2024-08-22
• Device Publish Date: 2024-08-14

Devices Manufactured by NUSMILE, LTD.

• 00810118105524 - NuSmile BioFlx Anterior Central and Lateral - Mini Kit: 2024-08-22NuSmile BioFlx Anterior Central and Lateral - Mini Kit - 20 Crowns
• 00810118105524 - NuSmile BioFlx Anterior Central and Lateral - Mini Kit: 2024-08-22 NuSmile BioFlx Anterior Central and Lateral - Mini Kit - 20 Crowns
• 00810118105531 - NuSmile BioFlx Cuspid - Mini Kit: 2024-08-22 NuSmile BioFlx Cuspid - Mini Kit - 20 Crowns
• 00810118105548 - NuSmile BioFlx Narrow - First Primary Molar - Starter Kit: 2024-08-22 NuSmile BioFlx Narrow - First Primary Molar - Starter Kit - 32 Crowns
• 00810118104565 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 1 Right - Regular Length / Light Shade
• 00810118104572 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 2 Right - Regular Length / Light Shade
• 00810118104589 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 3 Right - Regular Length / Light Shade
• 00810118104596 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 4 Right - Regular Length / Light Shade
• 00810118104602 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 5 Right - Regular Length / Light Shade