NeoLINER LC 1 g Kit

GUDID 00810092939276

NeoLINER LC 1 g Kit - 1 g + 15 Tips

NUSMILE, LTD.

Dental composite resin

• Primary Device ID: 00810092939276
• NIH Device Record Key: 3685bf93-2f66-49f3-9f25-ed02b83e0a65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoLINER LC 1 g Kit
• Version Model Number: NNLSK
• 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	00810092939276 [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: 2022-07-26
• Device Publish Date: 2022-07-18

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