Nexcomp Flow 0.5 B3

GUDID 08806387893660

Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowable resin.

Meta Biomed Co., Ltd.

Dental composite resin

• Primary Device ID: 08806387893660
• NIH Device Record Key: 739e40f2-2406-4fec-b41f-f3e923ad1d2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexcomp Flow 0.5 B3
• Version Model Number: 9366
• Company DUNS: 688322841
• Company Name: Meta Biomed Co., 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806387893660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080305

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2021-09-02
• Device Publish Date: 2021-08-25

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