NuSmile NuNamel 38% Silver Diamine Fluoride (SDF)

GUDID 00810118104503

NuSmile NuNamel 38% Silver Diamine Fluoride (SDF) liquid - 4.0 ml bottle

NUSMILE, LTD.

Dental coating, tooth-desensitizing, professional

• Primary Device ID: 00810118104503
• NIH Device Record Key: 30b74afb-2fa5-49df-822a-0ce4f8c28621
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuSmile NuNamel 38% Silver Diamine Fluoride (SDF)
• Version Model Number: NSSDF
• Company DUNS: 185497372
• Company Name: NUSMILE, LTD.
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810118104503 [Primary]

FDA Product Code

• PHR: Diammine Silver Fluoride Dental Hypersensitivity Varnish

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: 2025-03-18
• Device Publish Date: 2025-03-10

Devices Manufactured by NUSMILE, LTD.

• 00810118106415 - Avalon Biomed NeoSolv: 2025-03-27 Avalon Biomed NeoSolv - 4 oz Bottle
• 00810118106422 - Avalon Biomed NeoSolv: 2025-03-27 Avalon Biomed NeoSolv - 8 oz Bottle
• 00810118103667 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 50 pk Kit - Strawberry
• 00810118103674 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 50 pk Kit - Mint
• 00810118103681 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 50 pk Kit - Bubblegum
• 00810118103698 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Strawberry
• 00810118103704 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Mint
• 00810118103711 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Bubblegum