NuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU)

GUDID 00810118103995

NuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU)

NUSMILE, LTD.

Dental composite resin

• Primary Device ID: 00810118103995
• NIH Device Record Key: 6d5cee18-dc4b-4296-8f6c-cf70dee56efe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU)
• Version Model Number: NNLSP
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00810118103995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202413

FDA Product Code

• EJK: Liner, Cavity, Calcium Hydroxide

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: 2023-12-08
• Device Publish Date: 2023-11-30

Devices Manufactured by NUSMILE, LTD.

• 00810118106576 - Avalon Biomed NeoSEALER EZFlo 2.2 g Refill Syringe: 2025-08-11 Avalon Biomed NeoSEALER EZFlo 2.2 g Refill Syringe
• 00810118106439 - NuSmile NuNamel Pit & Fissure Sealant Brush Tip: 2025-08-01 NuNamel Pit & Fissure Sealant Brush Tip - 15 Pack
• 00810118106446 - NuSmile NuNamel Pit & Fissure Sealant Brush Tip: 2025-08-01 NuNamel Pit & Fissure Sealant Brush Tip - 20 Pack
• 00810118106453 - NuSmile NuNamel Pit & Fissure Sealant Brush Tip: 2025-08-01 NuNamel Pit & Fissure Sealant Brush Tip - 50 Pack
• 00810118106460 - NuSmile NuNamel Pit & Fissure Sealant: 2025-08-01 NuNamel Pit & Fissure Sealant 1 x 1.2 ml syringe + 15 tips Starter Kit
• 00810118106477 - NuSmile NuNamel Pit & Fissure Sealant: 2025-08-01 NuNamel Pit & Fissure Sealant 4 x 1.2 ml syringe + 20 tips Professional Kit
• 00810118106484 - NuSmile NuNamel Pit & Fissure Sealant: 2025-08-01 NuNamel Pit & Fissure Sealant 10 x 1.2 ml syringes (no tips) Value Kit
• 00810118106491 - Dentsply ProRoot BioSealer 2.2 g Kit, 20 Basic Flex Tips: 2025-07-23 Dentsply ProRoot BioSealer 2.2 g Kit, 20 Basic Flex Tips