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.

• 00810118105586 - Avalon Biomed NeoSEALER Flo 2.2 g syringe + 20 Basic Flex Tips Kit: 2025-02-06 For use in obturating root canals as part of orthograde root canal therapy with gutta percha.
• 00810118105630 - Avalon Biomed by Zarc Z-Fit Gutta Percha - Narrow 15: 2025-02-06 60 units
• 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