NuSmile BioFlx Narrow - First Primary Molar - Starter Kit

GUDID 00810118105548

NuSmile BioFlx Narrow - First Primary Molar - Starter Kit - 32 Crowns

NUSMILE, LTD.

Preformed dental crown, temporary

• Primary Device ID: 00810118105548
• NIH Device Record Key: 7ad49186-580b-4537-8aac-d18e2cc5392f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuSmile BioFlx Narrow - First Primary Molar - Starter Kit
• Version Model Number: SKD407L
• 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	00810118105548 [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.

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• 00810118105647 - Avalon Biomed by Zarc Z-Fit Gutta Percha - Wide 30: 2025-02-06 60 units
• 00810118105654 - Avalon Biomed by Zarc Z-Fit Sterile Paper Points - Narrow 15: 2025-02-06 180 units
• 00810118105661 - Avalon Biomed by Zarc Z-Fit Sterile Paper Points - Wide 30: 2025-02-06 180 units
• 00810118105678 - NuSmile Pre-Contoured Stainless Steel Crown: 2024-12-23 NuSmile Pre-Contoured Stainless Steel Crown - First Primary Molar, Maxillary Left, Size 5
• 00810118105685 - NuSmile Pre-Contoured Stainless Steel Crown: 2024-12-23 NuSmile Pre-Contoured Stainless Steel Crown - First Primary Molar, Maxillary Right, Size 5
• 00810118105692 - NuSmile Pre-Contoured Stainless Steel Crown: 2024-12-23 NuSmile Pre-Contoured Stainless Steel Crown - Second Primary Molar, Maxillary Left, Size 3