NuSmile NuNamel Varnish

GUDID 00810118103681

NuSmile NuNamel Varnish Unit Dose 50 pk Kit - Bubblegum

NUSMILE, LTD.

Dental cavity varnish

• Primary Device ID: 00810118103681
• NIH Device Record Key: beeda4b3-e97f-460c-8a0a-adff33ae69ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuSmile NuNamel Varnish
• Version Model Number: NNVB50
• 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	00810118103681 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132109

FDA Product Code

• LBH: Varnish, Cavity

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: 2025-03-26
• Device Publish Date: 2025-03-18

On-Brand Devices [NuSmile NuNamel Varnish]

• 00810118103711: NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Bubblegum
• 00810118103704: NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Mint
• 00810118103698: NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Strawberry
• 00810118103681: NuSmile NuNamel Varnish Unit Dose 50 pk Kit - Bubblegum
• 00810118103674: NuSmile NuNamel Varnish Unit Dose 50 pk Kit - Mint
• 00810118103667: NuSmile NuNamel Varnish Unit Dose 50 pk Kit - Strawberry