NuSmile NuNamel Pit & Fissure Sealant

GUDID 00810118106477

NuNamel Pit & Fissure Sealant 4 x 1.2 ml syringe + 20 tips Professional Kit

NUSMILE, LTD.

Dental unfilled resin sealant/coating

• Primary Device ID: 00810118106477
• NIH Device Record Key: 66a28812-9f41-4cca-9b79-6e126d3d231b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuSmile NuNamel Pit & Fissure Sealant
• Version Model Number: NNSPK
• 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	00810118106477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112517

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

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: 2025-08-01
• Device Publish Date: 2025-07-24

On-Brand Devices [NuSmile NuNamel Pit & Fissure Sealant]

• 00810118106484: NuNamel Pit & Fissure Sealant 10 x 1.2 ml syringes (no tips) Value Kit
• 00810118106477: NuNamel Pit & Fissure Sealant 4 x 1.2 ml syringe + 20 tips Professional Kit
• 00810118106460: NuNamel Pit & Fissure Sealant 1 x 1.2 ml syringe + 15 tips Starter Kit